Surgical kit for knee osteotomies and corresponding preoperative planning method

ABSTRACT

A surgical kit for performing a bone surgery, the surgical kit comprising an anchor module configured to be secured to a patient&#39;s bone with a removable module interface extending outwardly from an operative side of the anchor module; a cutting module configured to be superposable against the patient&#39;s bone, the cutting module having a slot extending therethrough along a plane and opening on a cutting module bone interface side and a cutting module operative side, wherein a bone-contacting surface of the anchor module is configured to contact the patient&#39;s bone on both sides of the plane; the cutting module being spaced from the anchor module by an open space, with and first and second connecting members connecting the cutting module to the anchor module.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/722,403, filed Aug. 24, 2018, entitled “SURGICAL KIT FOR KNEEOSTEOTOMIES AND CORRESPONDING PREOPERATIVE PLANNING METHOD”, theentirety of which is incorporated herein by reference.

TECHNICAL FIELD

The technical field generally relates to tools used in knee osteotomyprocedures, and more particularly in high tibial osteotomies.

BACKGROUND

Knee osteotomies are orthopedic procedures which aim to correct thealignment of knee joints to adjust pressure distribution. A high tibialosteotomy is a type of knee osteotomy which involves correcting thealignment of a knee joint by reconfiguring the mechanical axis of thetibia. Depending on the required correction angle, the high tibialosteotomy can be an open wedge osteotomy or a closed wedge osteotomy. Inan open wedge osteotomy, a planar cut is made in the tibia below theknee, and the tibia bone is opened along the planar cut to form awedge-shaped opening with a specified angle. In a closed wedgeosteotomy, a wedge of bone having a specified angle is removed from thetibia bone below the knee, and the tibia bone is closed along the wedge.After the bone is opened or closed, it is retained in place byinstalling a fixation plate. The opening or closing effectively adjuststhe angle of the tibia relative to the femur, thereby reconfiguring howpressure between the tibia and the femur is distributed in the knee.

Existing tools and procedures are limited in the accuracy and precisionwith which the alignment of the knee can be corrected. There istherefore much room for improvement.

SUMMARY

According to an aspect, a preoperative planning method for a high-tibialknee osteotomy procedure is provided. The method includes the steps of:a) constructing a 3D model of a patient's bones; b) analyzing the 3Dmodel to select a desired correction angle to apply to the patient'stibia bone to adjust a mechanical axis thereof; c) determining surgicalsteps required to apply the desired correction angle to the patient'stibia bone; d) designing a patient-specific guide to guide genericsurgical tools in performing the surgical steps, the patient-specificguide being designed to conform to the anatomy of the patient's bonesusing the 3D model; and e) manufacturing the patient-specific guidedesigned in step d).

According to an aspect, a computer system is provided. The computersystem is configured to: a) receive a 3D model of a patient's bones; b)analyze the 3D model to select a desired correction angle to apply tothe patient's tibia bone to adjust a mechanical axis thereof; c)determine surgical steps required to apply the desired correction angleto the patient's tibia bone; d) design a patient-specific guide to guidegeneric surgical tools in performing the surgical steps, thepatient-specific guide being designed to conform to the anatomy of thepatient's bones using the 3D model; and e) transmit instructions to amanufacturing device to manufacture the patient-specific guide designedin step d).

According to an aspect, a non-transitory computer-readable medium isprovided. The non-transitory computer-readable medium has instructionsstored thereon which, when executed by the computer, cause the computerto perform the steps of: a) receiving a 3D model of a patient's bones;b) analyzing the 3D model to select a desired correction angle to applyto the patient's tibia bone to adjust a mechanical axis thereof; c)determining surgical steps required to apply the desired correctionangle to the patient's tibia bone; d) designing a patient-specific guideto guide generic surgical tools in performing the surgical steps, thepatient-specific guide being designed to conform to the anatomy of thepatient's bones using the 3D model; and e) transmitting instructions toa manufacturing device to manufacture the patient-specific guidedesigned in step d).

According to an aspect, a surgical kit for performing a high-tibial kneeosteotomy is provided. The surgical kit includes a plurality of generictools, and at least one patient-specific guide configured to cooperatewith the generic tools to guide the same in performing steps of thehigh-tibial knee osteotomy procedure as determined according to apreoperative plan.

According to an aspect, a fixation plate for securing an opening formedin a bone is provided. The fixation plate includes: a body securable tothe bone, the body having a bone interface side and an outward facingside; and a wedge element extending from the bone interface side of thebody for inserting into the opening formed in the bone; wherein thewedge element is shaped to conform to contours of the opening formed inthe bone.

In an embodiment, the wedge element includes a proximal abutment forabutting against a proximal internal surface of the bone in the opening,and a distal abutment for abutting against a distal internal surface ofthe bone in the opening.

In an embodiment, the proximal and distal abutments have respectivebearing surfaces sized to abut against cortical sections of the proximaland distal internal surfaces of the bone.

In an embodiment the wedge element extends along a width between ananterior side and a posterior side of body, further wherein at least oneof the bearing surfaces is tapered along the width.

In an embodiment, the wedge element extends from the body along a depth,further wherein at least one of the bearing surfaces is tapered alongthe depth.

In an embodiment, the bearing surfaces extend between anterior andposterior side edges, further wherein at least one of the anterior andposterior side edges are tapered.

In an embodiment, the bearing surfaces of the proximal and distalabutments have respective surface areas which are different from oneanother.

In an embodiment, the bearing surfaces of the proximal and distalabutments are offset from one another.

In an embodiment, the proximal and distal abutments are spaced apartfrom one another via a canal.

In an embodiment, the canal is an evolutive canal having a shape whichprogressively changes along a width of the wedge element.

In an embodiment the canal is shaped with a curved depth profile.

In an embodiment, the wedge element comprises an anterior wedge memberpositioned proximate to an anterior side of plate body, and a posteriorwedge member positioned proximate to a posterior side of plate body.

In an embodiment, the anterior and posterior wedge members are spaceapart from one another via an opening in the plate body.

In an embodiment, the wedge element comprises an anterior sectionextending from a posterior side of the plate body along a width, and aposterior section extending from the anterior section along a width.

In an embodiment, the anterior and posterior sections of wedge elementtogether define an extended wedge element having a curved profilefollowing a contour of the bone.

In an embodiment, the extended wedge element is shaped to extend alongat least a first face of the bone, and a second face of the boneposterior to the first face.

According to an aspect, a fixation plate for securing an opening formedin a bone is provided. The fixation plate includes: a body securable tothe bone, the body having a bone interface side and an outward facingside; and a wedge element extending from the bone interface side of thebody for inserting into the opening formed in the bone; wherein thewedge element comprises a proximal abutment for abutting against aproximal internal surface of the bone in the opening, and a distalabutment for abutting against a distal internal surface of the bone inthe opening, said proximal and distal abutments being spaced apart fromone another via a canal.

In an embodiment, the canal is an evolutive canal, having a shape whichprogressively changes along a width of the wedge element.

According to an aspect, a method for designing a patient-specificfixation plate is provided. The method includes the steps of: a)obtaining 3D model of the patient's bone; b) determining an expectedshape of an opening to be formed in the patient's bone using the 3Dmodel; c) designing a fixation plate having a body and a wedge elementextending therefrom, and configuring the wedge element to conform to theexpected shape of the opening; and d) manufacturing the fixation plateaccording to the design.

In an embodiment, the method further includes the steps of determining adesired amount of flexure to allow in the wedge element and configuringthe wedge element with an evolutive canal to allow the desired amount offlexure subject to a load applied thereacross.

According to an aspect, a spacing element for spacing a fixation plateaway from a bone to which the fixation plate is secured is provided. Thespacing element has a body with a bone interface side and a plateinterface side and sidewalls extending thereinbetween, said boneinterface side having a bone contacting surface having contoursconforming to surface contours of the bone.

In an embodiment, the sidewalls define a central aperture extendingthrough the body for receiving a fastener therethrough, the centralaperture opening on the bone interface side and on the plate interfaceside.

In an embodiment, the plate interface side has a plate contactingsurface which is substantially planar.

In an embodiment, the plate interface side has a plate contactingsurface having contours conforming to surface contours of the plate.

In an embodiment, the plate interface side is configured to engage withthe plate in a predetermined orientation.

In an embodiment, the body is substantially cylindrical in shape.

In an embodiment, the body is made from a rigid, biocompatible material.

In an embodiment, body is made from metal.

According to an aspect, a fixation plate kit is provided. The fixationplate kit includes: a fixation plate having a body with a bone interfaceside and an outward facing side, the body having a plurality of fastenerapertures defined therein for receiving fasteners to secure the fixationplate to a bone; and a plurality of spacing elements for positioningbetween the fixation plate and the bone when the fixation plate issecured to the bone, each of the spacing elements having a body with abone interface side for contacting the bone, a plate interface side forcontacting the plate, and sidewalls extending between the bone interfaceside and the plate interface side, the bone interface side of thespacing elements having a bone contacting surface with contoursconforming to surface contours of the bone.

In an embodiment, the fixation plate is configured to secure to apredetermined position on the bone, further wherein the bone interfaceside of the fixation plate has contours following surface contours ofthe bone at the predetermined position.

In an embodiment, each of the plurality of spacing elements isconfigured to interface with the bone at predetermined positionsrelative thereto, further wherein the bone contacting surfaces of theplurality of spacing elements have surface contours conforming to thesurface contours of the bone at the predetermine positions.

In an embodiment, each of the plurality of spacing elements isconfigured to interface with the fixation plate at predeterminepositions relative thereto, further wherein the bone contacting surfacesof the plurality of spacing elements have surface contours conforming tothe surface contours of the bone at the predetermined positions.

In an embodiment, each of the plurality of spacing elements isconfigured to interface with the fixation plate in alignment with acorresponding one of the fastener apertures.

In an embodiment, the sidewalls of the spacing elements definethicknesses thereof, further wherein each of the plurality of spacingelements is configured with a thickness to provide a uniform spacingbetween the bone and the bone interface side of the fixation plate body.

In an embodiment, the body has recesses defined on the bone interfaceside thereof configured to engage with corresponding spacing elements.

According to an aspect, a fixation plate for securing to a bone isprovided. The fixation plate includes: a body having a bone interfaceside and an outward facing side, the bone interface side having surfacecontours conforming to surface contours of a predetermined position ofthe bone; and a plurality of spacing elements extending from the boneinterface side for spacing the bone interface side of the body away fromthe bone when the fixation plate is secured thereto.

In an embodiment, each of the plurality of spacing elements has a bonecontacting surface with contours conforming to the surface contours ofthe predetermined position of the bone.

In an embodiment, the fixation plate body has a plurality of fastenerapertures defined therein for receiving fasteners to secure the fixationplate to the bone, further wherein the spacing elements are positionedin alignment with the fastener apertures.

In an embodiment, the spacing element comprises annular bumps extendingfrom the fixation plate body around the fastener apertures on the boneinterface side of the body.

In an embodiment, the spacing element is integrally formed as part ofthe fixation plate body.

According to an aspect, a surgical guide assembly for performing a kneeosteotomy procedure is provided. The assembly includes: a body forsecuring to a patient's tibia bone; and a plurality of guide modulesremovably attached to the body, each guiding module being adapted toreceive a corresponding surgical tool and to guide the correspondingsurgical tool along a predetermined path during the knee osteotomyprocedure.

In an embodiment, the plurality of guide modules includes at least onedrilling module removably secured to the body, each drilling moduleincluding a plurality of drill guides for cooperating with a pluralityof corresponding drill bits to guide a position, depth, and anglethereof to form drill holes in the patient's tibia bone in apredetermined configuration to weaken the patient's tibia bone inpreparation for forming a cut therein.

In an embodiment, the drill guides are positioned and oriented in aco-planar, parallel arrangement to define parallel drill holes in thepatient's bone in a common plane.

In an embodiment, the drill guides include a first group of paralleldrill guides for creating drill holes in a first plane, and a secondgroup of parallel drill guides for creating drill holes in a secondplane.

In an embodiment, the body has a drill module interface adapted forselectively connecting one of the at least one drilling module.

In an embodiment, the at least one drilling module includes a firstdrilling module for guiding drill bits to form drill holes in a firstparallel orientation in a common plane and a second drilling module forguiding drill bits to form drill holes in a second parallel orientationdifferent from the first parallel orientation, and in the same commonplane.

In an embodiment, the plurality of guide modules further includes acutting module secured to the body, the cutting module including a slotsized and shaped to receive a corresponding osteotome therein, and toguide the osteotome to cut the patient's tibia bone at a position,angle, and depth corresponding to an area of the patient's tibia boneweakened by the drilling module.

In an embodiment, the cutting module is positioned adjacent thepatient's tibia bone, and the drilling module is positioned adjacent thecutting module.

In an embodiment, the body includes an anchor module for anchoringremovable modules relative to the patient's bone, the anchor moduleincluding a removable module interface for selectively interfacing withone of the guiding modules.

In an embodiment, the removable module interface includes at least oneaperture for receiving corresponding protrusions extending from aremovable module.

In an embodiment, the body includes a first section and a second sectiondetachably connected to the first section.

In an embodiment, the second section is configured to be secured to ananterior surface of the patient's tibia bone, and the first section isconfigured to be secured to the patient's tibia bone lateral relative tothe second section, the anchor module being provided in the firstsection.

In an embodiment, the first and second sections are independentlysecurable relative to the patient's tibia bone to allow one of the firstand second sections to be removed from the patient's tibia bone whilethe other one of the first and second sections remains secured to thepatient's tibia bone.

In an embodiment, the anchor module includes a proximal sectionpositioned proximate the joint between the patient's femur and tibiabones, and a distal section spaced further away from the joint betweenthe femur and tibia.

In an embodiment, the proximal and distal sections are separable fromone another to allow them to move independently while being secured todifferent sections of the patient's tibia bone.

In an embodiment, the plurality of guide modules further includes apredrilling module for predrilling holes in the patient's tibia bone forreceiving fasteners to secure at least one of a plate and an implant tothe patient's tibia bone.

In an embodiment, the predrilling module includes a predrilling modulebody having a bone interface side for abutting against the patient'stibia bone, an operative side opposite the bone interface side and aplurality of drill guides extending from the operative side for guidingcorresponding drill bits.

In an embodiment, the predrilling module further includes an attachmentmechanism for at least one of securing the predrilling module relativeto the patient's tibia bone and assuring proper alignment of thepredrilling module relative to the patient's tibia bone.

In an embodiment, the attachment mechanism includes an attachmentinterface for interfacing with the removable module interface of theanchor module to attach the predrilling module to the anchor module, theattachment mechanism allowing the predrilling module to be positioned inonly one position when attached to the anchor module.

In an embodiment, the attachment interface includes two protrusionssized and shaped to engage in corresponding apertures of the anchormodule.

In an embodiment, the protrusions are positioned to align with theanchor module while the patient's tibia bone is in a closedconfiguration to allow the predrilling module to engage with thepatient's tibia bone and predrill holes prior to opening the bone.

In an embodiment, the assembly further includes a spreader moduleconfigured to operate in cooperation with the anchor module for openingthe patient's tibia bone along a planar cut formed therein.

In an embodiment, the spreader module includes an upper arm and a lowerarm pivotally connected to one another via a hinge, each one of theupper and lower arms having a load end and an effort end, the upper andlower arms being pivotable such that movement of the effort ends of theupper and lower arms towards one another moves the load ends of theupper and lower arms away from each other.

In an embodiment, the anchor module includes a proximal section and adistal section positioned on the patient's tibia bone on opposite sidesof the planar cut, the upper arm including a protrusion for engagingwith the proximal section and the lower arm including a protrusion forengaging with the distal section.

In an embodiment, at least some of the plurality of guide modules areremovably and interchangeably attachable to the body.

In an embodiment, the body includes a bone interface side for abuttingagainst the patient's tibia bone, the bone interface side including asurface having contours complementary in shape to the surface contoursof a predetermined area of the patient's tibia bone.

According to an aspect, a tool for spreading and/or contracting a bonealong a cut formed therein as part of a knee osteotomy procedure isprovided. The spreading tool includes: an upper arm and a lower armrespectively extending along a length between an effort end and a loadend, the upper and lower arms being pivotally connected to one anothervia a hinge positioned between the effort and load ends; and an anchorinterface proximate the load ends for respectively anchoring the loadends of the upper and lower arms relative to respective first and secondfixed positions on the bone; the tool being operable, via rotation ofthe upper and/or lower arms about the hinge, between a closedconfiguration in which the load ends of the upper and lower arms areproximate one another and an open configuration in which the load endsof the upper and lower arms are spaced apart from one another.

In an embodiment, the upper and lower arms extend opposite one anotherbetween the effort and load ends.

In an embodiment, the upper and lower arms are substantially arcuated,and extend away from one another between the hinge and the load endsand/or between the hinge and the effort ends.

In an embodiment, the anchor interface is adapted to engage in an anchormodule secured on a surface of the bone.

In an embodiment, the anchor interface includes protrusions extendingfrom the load ends of the upper and lower arms, said protrusions beingadapted tor respectively engage in first and second anchoring points ofthe anchor module positioned on the bone on opposite sides of the cut.

In an embodiment, the protrusions extend substantially perpendicularlyfrom the arms.

In an embodiment, the protrusions are cylindrical and have respectivecylindrical axes.

In an embodiment, the protrusions are adapted to rotate about theirrespective cylindrical axis relative to the anchoring points in whichthey are respectively engaged.

In an embodiment, the tool further includes an actuating assemblyoperatively connected to the effort ends of the upper and lower arms,operable to pivot the upper and/or lower arms about the hinge.

In an embodiment, the upper and lower arms respectively have a threadedbore extending therethrough proximate the effort ends, and wherein theactuating assembly comprises a screw mechanism extending through thethreaded bores and being adapted to pivot the arms about the hinge uponrotation of the screw mechanism.

In an embodiment, the screw mechanism is adapted to retain the spacingof effort ends when the actuating assembly is not operated.

In an embodiment, the actuating assembly further comprises a hand wheelconnected to the screw mechanism for facilitating rotation of the screwmechanism by hand.

In an embodiment, the tool further includes a gauge extending betweenthe upper and lower arms for indicating a magnitude of an opening angledefined between the load ends.

In an embodiment, the gauge includes a scale connected to the upper arm,and movable through an aperture provided in the lower arm.

In an embodiment, the lower arm includes a window communicating with theaperture to allow reading the scale through the window.

In an embodiment, the upper and lower arms are made from a rigidmaterial.

In an embodiment, the upper and lower arms are made from 3D-printablematerial.

According to an aspect, a tool for spreading and/or contracting a bonealong a cut formed therein as part of a knee osteotomy procedure isprovided. The tool includes: an upper arm and a lower arm respectivelyextending along a length between an effort end and a load end, the upperand lower arms being pivotally connected to one another via a hingepositioned between the effort and load ends; an anchor interfaceproximate the load ends for respectively anchoring the load ends of theupper and lower arms relative to respective first and second anchoringpoints on opposite sides of the cut in the bone; the tool being operabletowards an open configuration in which a spreading force is appliedacross the first and second anchoring points via the load ends, andtowards a closed configuration in which a contracting force is appliedacross the first and second anchoring points via the load ends.

In an embodiment, the upper and lower arms extend opposite one anotherbetween the effort and load ends.

In an embodiment, the upper and lower arms are substantially arcuated,and extend away from one another between the hinge and the load endsand/or between the hinge and the effort ends.

In an embodiment, the anchor interface comprises protrusions extendingfrom the load ends for interfacing with the anchoring points.

In an embodiment, the protrusions extend substantially perpendicularlyfrom the arms.

In an embodiment, the protrusions are cylindrical and have respectivecylindrical axes.

In an embodiment, the protrusions are adapted to rotate about theirrespective cylindrical axis relative to the anchoring points in whichthey are respectively engaged.

In an embodiment, the tool further includes an actuating assemblyoperatively connected to the effort ends and being operable to apply theforce thereto.

In an embodiment, the upper and lower arms respectively have a threadedbore extending therethrough proximate the effort end, and wherein theactuating assembly comprises a screw mechanism extending through thethreaded bores for pivoting the arms about the hinge upon rotation ofthe screw mechanism.

In an embodiment, the screw mechanism is adapted to retain the spacingof effort ends when the actuating assembly is not operated.

In an embodiment, the actuating assembly further comprises a hand wheelconnected to the screw mechanism, for facilitating rotation of the screwmechanism by hand.

In an embodiment, the tool further includes a gauge extending betweenthe upper and lower arms for indicating a magnitude of an opening angledefined between the load ends.

In an embodiment, the gauge comprises a scale connected to the upperarm, and movable through an aperture provided in the lower arm.

In an embodiment, the lower arm comprises a window communicating withthe aperture to allow reading the scale through the window.

In an embodiment, the upper and lower arms are made from a rigidmaterial.

In an embodiment, the upper and lower arms are made from 3D-printablematerial.

According to an aspect, a patient-specific tool is provided forperforming a knee osteotomy procedure on a patient's tibia bone having awedge opening having a top interior surface and a bottom interiorsurface. The tool includes: a body including a wedge element sized andshaped to fit in the wedge opening, the wedge element having at leastone bone contacting surface having contours complementary in shape tothe surface contours of the top and bottom interior surfaces of thepatient's tibia bone.

In an embodiment, the body includes a handle end to facilitatemanipulation of the tool during the knee osteotomy procedure and anoperative end comprising the wedge element, the wedge element beingshaped and configured to fit snugly in the wedge opening in thepatient's tibia bone based on the expected shape thereof as determinedaccording to a pre-operative plan.

In an embodiment, the wedge element includes a top surface shaped toconform to the contour of the top interior surface of the patient'stibia bone and a bottom surface shaped to conform to the contour of thebottom interior surface of the patient's tibia bone.

In an embodiment, the operative end of the body further includes a tabelement to limit the insertion depth of the wedge element into the wedgeopening.

In an embodiment, the tab element is shaped to conform to the exteriorcontours of the patient's tibia bone.

In an embodiment, the tab element includes a top surface shaped toconform to the exterior contour of the patient's tibia bone above thewedge opening, and a bottom surface shaped to conform to the exteriorcontour of the patient's tibia bone below the wedge opening.

In an embodiment, the handle end includes a handle to allow the tool tobe easily grasped and manipulated by hand.

In an embodiment, the handle has a rectangular-shaped profile andincludes an anterior side and a lateral side, the anterior and lateralsides being marked to indicate proper orientation during the procedure.

In an embodiment, the body includes a bone interface side configured tobe positioned against the patient's tibia bone and an operative sidecomprising a plurality of drill guides extending therefrom for guidingcorresponding drill bits for predrilling holes in the patient's tibiabone for receiving fasteners to secure one of a plate and an implant tothe patient's tibia bone.

In an embodiment, the bone interface side comprises a bone-contactingsurface having contours complementary in shape to the surface contoursof the patient's tibia bone, the wedge element extending from the boneinterface side.

In an embodiment, the body includes a proximal section for positioningadjacent a surface of the patient's bone above the wedge opening, adistal section for positioning adjacent a surface of the patient's bonebelow the wedge opening and an intermediate section for spanning thewedge opening, the wedge element being located on the intermediatesection.

According to an aspect, a patient-specific opening validating tool isprovided for validating a wedge opening of a patient's tibia bone duringa knee osteotomy procedure. The tool includes: a body having a handleend to facilitate manipulation of the tool during the knee osteotomyprocedure and an operative end comprising a wedge element shaped andconfigured to fit snugly in the wedge opening in the patient's tibiabone based on the expected shape thereof as determined according to apre-operative plan.

In an embodiment, the wedge element includes a top surface shaped toconform to the contour of the top interior surface of the patient'stibia bone and a bottom surface shaped to conform to the contour of thebottom interior surface of the patient's tibia bone.

In an embodiment, the operative end of the body further comprises a tabelement to limit the insertion depth of the wedge element into the wedgeopening.

In an embodiment, the tab element is shaped to conform to the exteriorcontours of the patient's tibia bone.

In an embodiment, the tab element comprises a top surface shaped toconform to the exterior contour of the patient's tibia bone above thewedge opening, and a bottom surface shaped to conform to the exteriorcontour of the patient's tibia bone below the wedge opening.

In an embodiment, the handle end includes a handle to allow the tool tobe easily grasped and manipulated by hand.

In an embodiment, the handle has a rectangular-shaped profile andincludes an anterior side and a lateral side, the anterior and lateralsides being marked to indicate proper orientation during the procedure.

According to an aspect, a method is provided for validating a wedgeopening of a patient's tibia bone during a knee osteotomy procedure, thewedge opening having top and bottom interior surfaces, the methodincluding the steps of: providing an opening validating tool including abody having a handle end and an operative end comprising a wedge elementshaped and configured to fit snugly in the wedge opening in thepatient's tibia bone based on the expected shape thereof as determinedaccording to a pre-operative plan; inserting the opening validating toolinto the wedge opening using the handle end such that the wedge elementconforms to the contour of interior surfaces of the wedge opening,wherein a snug fit of the wedge element confirms that the correctopening has been formed and an incorrect fit of the wedge elementindicates that an adjustment of the wedge opening is necessary.

According to an aspect, a patient-specific predrilling guide is providedfor performing a knee osteotomy procedure on a patient's tibia bone, thepatient's tibia bone having a wedge opening having a top interiorsurface and a bottom interior surface. The guide includes: a body forsecuring to the patient's tibia bone, the body having a bone interfaceside configured to be positioned against the patient's tibia bone and anoperative side comprising a plurality of drill guides extendingtherefrom for guiding corresponding drill bits for predrilling holes inthe patient's tibia bone for receiving fasteners to secure one of aplate and an implant to the patient's tibia bone; and a wedge elementextending from bone interface side, the wedge element having at leastone bone contacting surface having contours complementary in shape tothe surface contours of the top and bottom interior surfaces of thepatient's tibia bone to allow the guide to be secured at a predeterminedposition relative to the wedge opening.

In an embodiment, the bone interface side has contours complementary inshape to the surface contours of the patient's tibia bone.

In an embodiment, the body includes a proximal section for positioningadjacent a surface of the patient's bone above the wedge opening, adistal section for positioning adjacent a surface of the patient's bonebelow the wedge opening and an intermediate section for spanning thewedge opening, the wedge element being located on the intermediatesection.

According to an aspect, a guide for guiding drill bits to form holes ina bone in a predetermined pattern for receiving fasteners to secure animplant to the bone, the guide including: a guide body having a boneinterface side opposite an operative side, the bone interface sideincluding a bone contacting surface engageable with a surface of thebone; and a plurality of drill guides extending from the operative sideof the guide body for guiding corresponding drill bits; wherein the bonecontacting surface of the guide body is configured to substantiallyconform to surface contours of the bone at a predetermined position onthe bone.

In an embodiment, each drill guide includes a guide barrel extendingfrom the operative side along a lengthwise axis and terminating at aterminal end.

In an embodiment, the guide barrels extend from the operative side atpredetermined angles and are positioned on the operative side accordingto the predetermined pattern.

In an embodiment, the guide barrels are adapted to limit insertion depthof the drill bits for forming holes in the bone having a predetermineddepth.

In an embodiment, each guide barrel includes sidewalls defining a guidetunnel extending through the guide barrel along the lengthwise axis, theguide tunnel having openings on the bone interface side and operativeside of the guide body configured to receive a corresponding drill bittherethrough.

In an embodiment, the sidewalls are adapted to constrain movement of thedrill bit to a predetermined depth, position and/or orientation relativeto the bone.

In an embodiment, the guide further includes a handle member connectedto the guide body adapted to facilitate manipulation and positioning ofthe guide body.

In an embodiment, the handle member is a rigid elongated memberextending from the operative side of the guide body.

In an embodiment, the guide body further comprises fastener aperturesfor receiving fasteners to secure the guide body to the bone.

In an embodiment, the guide barrels are positioned to assist in formingholes on either side of a planar cut formed in the bone.

In an embodiment, the guide body includes an alignment mechanismconfigured to engage with an anchor module secured on a surface of thebone and spanning transversely across the planar cut.

In an embodiment, the alignment mechanism includes an attachmentinterface for respectively interfacing with anchoring points of theanchoring module positioned on either side of the planar cut.

In an embodiment, the attachment interface is configured to interfacewith the anchoring points in only one orientation.

In an embodiment, the anchoring points include apertures, and whereinthe attachment interface comprises protrusions configured torespectively engage in the apertures.

In an embodiment, the guide is configured to assist in forming holes inthe bone prior to altering a geometry of the bone.

In an embodiment, the guide body is adapted to span across an openingformed along the planar cut, and includes a proximal section positionedabove the opening and a distal section positioned below the opening.

In an embodiment, the guide body further includes an intermediatesection spanning the opening between the proximal and distal sections,and an alignment mechanism extending from the intermediate section forengaging the bone to secure the guide body in a predetermined positionrelative to the bone.

In an embodiment, the alignment mechanism includes a wedge extendingfrom the intermediate section adapted to be inserted within the opening.

In an embodiment, the wedge includes contours configured to match innersurface contours of the opening.

In an embodiment, the guide is made from a rigid material.

In an embodiment, the guide is made from 3D-printable material.

According to an aspect, a method is provided for designing a guide forguiding drill bits to form holes in a bone in a predetermined patternfor securing a knee osteotomy implant on the bone prior to altering ageometry of the bone. The method includes the steps of: creating adigital 3D model of the bone; virtually cutting the 3D model of the boneto form a planar cut therein; virtually opening the 3D model of the bonealong the planar cut to a desired opening angle; virtually positioningan implant and corresponding fasteners on the 3D model of the bone toset final positions of drill holes; virtually closing the 3D model ofthe bone to determine corresponding initial positions of the drillholes; and designing the guide with drill guides positioned according tothe initial positions of the drill holes.

According to an aspect, a guide is provided for assisting in formingholes in a bone according to a predetermined pattern for receivingfasteners to secure an implant on the bone. The guide includes: a guidebody having a bone interface side opposite an operative side, the boneinterface side comprising a bone contacting surface engageable with asurface of the bone; and a plurality of drill guides connected to theoperative side of the guide body for guiding corresponding drill bitsadapted to form the holes, wherein the drill guides are positioned toguide drill bits to form holes in the bone in initial positions prior toa planned alteration of a geometry of the bone which will cause thedrill holes to move into final positions in alignment with fastenerapertures in the implant.

In an embodiment, the guide is custom made according to the anatomy ofthe bone such that the bone contacting surface substantially conforms tosurface contours of the bone at a predetermined position on the bone.

In an embodiment, each drill guide comprises a guide barrel extendingfrom the operative side along a lengthwise axis and terminating at aterminal end.

In an embodiment, the guide barrels extend from the operative side atpredetermined angles and are positioned on the operative side accordingto the predetermined pattern.

In an embodiment, the guide barrels are adapted to limit insertion depthof the drill bits for forming holes in the bone having a predetermineddepth.

In an embodiment, each guide barrel includes sidewalls defining a guidetunnel extending through the guide barrel along the lengthwise axis, theguide tunnel having openings on the bone interface side and operativeside of the guide body configured to receive a corresponding drill bittherethrough.

In an embodiment, the sidewalls are adapted to constrain movement of thedrill bit to a predetermined depth, position and/or orientation relativeto the bone.

In an embodiment, the guide further includes a handle member connectedto the guide body adapted to facilitate manipulation and positioning ofthe guide body.

In an embodiment, the handle member is a rigid elongated memberextending from the operative side of the guide body.

In an embodiment, the guide body further includes fastener apertures forreceiving fasteners to secure the guide body to the bone.

In an embodiment, the guide barrels are positioned to assist in formingholes on either side of a planar cut formed in the bone.

In an embodiment, the guide body comprises an alignment mechanismconfigured to engage with an anchor module secured on a surface of thebone and spanning transversely across the planar cut.

In an embodiment, the alignment mechanism includes an attachmentinterface for respectively interfacing with anchoring points of theanchoring module positioned on either side of the planar cut.

In an embodiment, the attachment interface is configured to interfacewith the anchoring points in only one orientation.

In an embodiment, the anchoring points include apertures, and theattachment interface includes protrusions configured to respectivelyengage in the apertures.

In an embodiment, the guide is made from a rigid material.

In an embodiment, guide is made from 3D-printable material.

According to an aspect, a guide is provided for guiding drill bits toform holes in a bone in a predetermined pattern for receiving fastenersto secure an implant to the bone. The guide includes: a guide bodyhaving a bone interface side opposite an operative side, the boneinterface side comprising a bone contacting surface engageable with asurface of the bone; a plurality of drill guides extending from theoperative side of the guide body for guiding corresponding drill bits;and an alignment mechanism connected to the guide body for engaging withanchoring points on the bone to secure the guide body in a predeterminedposition relative to the bone, wherein the bone contacting surface ofthe guide body is configured to substantially conform to surfacecontours of the bone at a predetermined position on the bone.

In an embodiment, each drill guide comprises a guide barrel extendingfrom the operative side along a lengthwise axis and terminating at aterminal end.

In an embodiment, the guide barrels extend from the operative side atpredetermined angles and are positioned on the operative side accordingto the predetermined pattern.

In an embodiment, the guide barrels are adapted to limit insertion depthof the drill bits for forming holes in the bone having a predetermineddepth.

In an embodiment, each guide barrel includes sidewalls defining a guidetunnel extending through the guide barrel along the lengthwise axis, theguide tunnel having openings on the bone interface side and operativeside of the guide body configured to receive a corresponding drill bittherethrough.

In an embodiment, the sidewalls are adapted to constrain movement of thedrill bit to a predetermined depth, position and/or orientation relativeto the bone.

In an embodiment, the guide further includes a handle member connectedto the guide body adapted to facilitate manipulation and positioning ofthe guide body.

In an embodiment, the handle member is a rigid elongated memberextending from the operative side of the guide body.

In an embodiment, the guide body further includes fastener apertures forreceiving fasteners to secure the guide body to the bone.

In an embodiment, the guide barrels are positioned to assist in formingholes on either side of a planar cut formed in the bone.

In an embodiment, the alignment mechanism is configured to engage withanchoring points on the surface of the bone on either sides of theplanar cut.

In an embodiment, the anchoring points comprise apertures, and thealignment mechanism includes protrusions configured to respectivelyengage in the apertures.

In an embodiment, the alignment mechanism is configured to engage theanchoring points in only one orientation.

In an embodiment, the guide is configured to assist in forming holes inthe bone prior to a altering a geometry of the bone.

In an embodiment, the guide body is adapted to span across an openingformed along the planar cut, and comprises a proximal section positionedabove the opening and a distal section positioned below the opening.

In an embodiment, the guide body further includes an intermediatesection spanning the opening between the proximal and distal sections,and an alignment mechanism extending from the intermediate section forengaging the bone to secure the guide body in a predetermined positionrelative to the bone.

In an embodiment, the alignment mechanism includes a wedge extendingfrom the intermediate section adapted to be inserted within the opening.

In an embodiment, the wedge includes contours configured to match innersurface contours of the opening.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a surgical guide secured to a patient'stibia bone, according to an embodiment; FIG. 1B is a top view of thesurgical guide of FIG. 1A, showing drill holes formed through a crosssection of the patient's tibia bone.

FIG. 2 is a side view of a drill bit configured to cooperate withcorresponding drill guides in the surgical guide of FIG. 1A, accordingto an embodiment; FIG. 2A is a side view of drill bits according toalternate embodiments having depth guides permanently secured relativeto their cutting ends.

FIGS. 3A and 3B are respectively medial and anterior perspective viewsof a predrilling module secured to an anchor module on the patient'stibia bone, according to an embodiment.

FIG. 4 is a perspective view of a spreading module, according to anembodiment;

FIGS. 4A and 4B are side views showing operation of a spreading modulerespectively in a closed configuration and an open configuration.

FIG. 5 is a perspective view of an opening validator, according to anembodiment; FIG. 5A is a cross sectional view showing the openingvalidator of FIG. 5 inserted into an open wedge formed in the patient'stibia bone.

FIG. 6A is a perspective view of a fixation plate securing an open wedgeformed in the patient's tibia bone, according to an embodiment; FIG. 6Bis a partial-cross section detail view of the fixation plate secureddirectly to the patient's tibia bone via a fastener.

FIG. 7 is a perspective view of a spacing element, according to anembodiment;

FIG. 7A is a cross sectional view of the spacing element of FIG. 7 takenalong 7A-7A.

FIG. 8 is a cross sectional view of a fixation plate secured to apatient's tibia bone via fasteners using spacing elements, according toan embodiment; FIGS. 8A, 8B and 8C are partial-cross section detailviews of the fixation plate spaced apart from the patient's bone atdifferent distances via different sizes of spacing elements.

FIG. 9 is a perspective view of a surgical guide secured to thepatient's tibia bone, according to an alternate embodiment in which theosteotome guide acts as an interface for connecting a removable drillingmodule.

FIG. 10A is a perspective view of the surgical guide of FIG. 9 ,including a first removable drilling module secured thereto via theosteotome guide; FIG. 10B is a top view of the surgical guide anddrilling module of FIG. 10A, showing drill bits forming drill holesthrough a cross section of the patient's tibia bone.

FIG. 11A is a perspective view of the surgical guide of FIG. 9 ,including a second removable drilling module secured thereto via theosteotome guide; FIG. 11B is a top view of the surgical guide anddrilling module of FIG. 11A, showing drill bits forming drill holesthrough a cross section of the patient's tibia bone.

FIG. 12A is a perspective view of a surgical guide secured to thepatient's tibia bone, according to an alternate embodiment in which theosteotome guide is configured to form a biplanar cut in the patient'sbone; FIG. 12B is a perspective view of the surgical guide of FIG. 12A,including a first removable drilling module secured thereto via theosteotome guide, the first removable drilling module being configured todrill along a first plane; FIG. 12C is a perspective view of thesurgical guide of FIG. 12A, including a second removable drilling modulesecured thereto via the osteotome guide, the second removable drillingmodule being configured to drill along the first plane and a secondplane; and FIG. 12D is a perspective view of the patient's tibia bonewith the anterior section of surgical guide of FIG. 12A removed, showingthe biplanar cut formed in the patient's tibia bone.

FIG. 13 is a perspective view of a predrilling module, according to analternate embodiment in which the predrilling module is configured todrill holes for the fixation plate after an open wedge has been formedin the patient's bone; FIGS. 13A and 13B are perspective views showingpositioning of the predrilling module of FIG. 13 and validating of theopening formed in the patient's bone.

FIG. 14 is a perspective view of a fixation plate securing an open wedgeformed in a patient's tibia bone, according to an embodiment in whichthe fixation plate is provided with a wedge element; FIGS. 14A, 14B and14C are respectively front perspective, rear perspective and side viewsof the fixation plate of FIG. 14 .

FIG. 15 is a side view of a portion of a fixation plate having a wedgeelement with an evolutive canal and patient-specific bone conformingsurfaces, according to an embodiment; FIG. 15A is a rear view of thefixation plate of FIG. 15 ; and FIG. 15B is a cross sectional view ofthe fixation plate of FIG. 15 taken along line 15B-15B.

FIG. 16 is a side view of section of a fixation plate having a straightwedge element, according to an embodiment; FIG. 16A is a rear viewthereof.

FIG. 17 is a perspective view of a fixation plate securing an open wedgeformed in a patient's tibia bone, according to an embodiment in whichthe fixation plate is provided with two wedge elements; FIGS. 17A and17B are respective front and rear views of the fixation plate of FIG. 17.

FIG. 18A is a side view of a portion of a fixation plate having twowedge elements, according to an embodiment; FIG. 18B is a rear view ofthe fixation plate of FIG. 18A.

FIG. 19 is a perspective view of a fixation plate securing an open wedgeformed in a patient's tibia bone, according to an embodiment in whichthe fixation plate is provided with a C-shaped wedge element.

FIG. 20 is a perspective view showing an open wedge formed in apatient's tibia bone supported by a straight wedge, according to anembodiment; FIG. 20A is a detail view of the wedge of FIG. 20 ; FIG. 20Bis a partial cross section of the bone and wedge of FIG. 20 , showingstress distribution at an interface between the wedge and the bone.

FIG. 21 is a perspective view showing an open wedge formed in apatient's tibia bone supported by a patient-specific, bone conformingwedge, according to an embodiment; FIG. 21A is a detail view of thewedge of FIG. 21 ; FIG. 21B is a partial cross section of the bone andwedge of FIG. 21 , showing stress distribution at an interface betweenthe wedge and the bone.

FIG. 22 is a side perspective view of an open wedge formed in apatient's tibia bone supported by a fixation plate with a boneconforming wedge having tapered bearing surfaces, according to anembodiment; FIG. 22A is a side view of the fixation plate of FIG. 22 .

FIG. 23 is a front perspective view of an open wedge formed in apatient's tibia bone supported by a fixation plate with a boneconfirming wedge having offset bearing surfaces, according to anembodiment; FIG. 23A is a detail view of the wedge element of thefixation plate of FIG. 23 .

FIG. 24A is a cross sectional view showing a fixation plate secured to apatient's tibia bone, according to an embodiment in which the fixationplate is provided with a single wedge element conforming to thepatient's cortical bone; FIG. 24B is a cross sectional view showing afixation plate secured to a patient's tibia bone, according to anembodiment in which the fixation plate is provided with two wedgeelements conforming to the patient's cortical bone; FIG. 24C is a crosssectional view showing a fixation plate secured to a patient's tibiabone, according to an embodiment in which the fixation plate is providedwith C-shaped wedge element conforming to the patient's cortical bone.

FIGS. 25A, 25B, 25C and 25D are respective front perspective, rearperspective, front and side views of a full contact plate, according toan embodiment; FIG. 25E is a detail view of a portion of FIG. 25Dshowing the contact surface and chamfered edge of the plate.

FIGS. 26A, 26B, 26C, 26D and 26E are respective front perspective, rearperspective, front, rear and side views of a low contact plate,according to an embodiment; FIG. 26F is a detail view of a portion ofFIG. 25E showing the contact surface and chamfered edge of the plate.

FIG. 27 is a perspective view of a fastener for a fixation plate,according to an embodiment; FIG. 27A is a detail view of the head of thefastener of FIG. 27 .

FIG. 28 is a perspective view of the fastener of FIG. 27 installed in afixation plate having a chamfered edge, according to an embodiment; FIG.28A is a partial cross-sectional view of the plate of FIG. 28 showing aseat for minimizing protrusion of the fastener head from the plate.

FIG. 29 is a partially transparent, perspective view of the fastener andplate for FIG. 28 , showing permitted angulation of the fastenerrelative to the plate.

FIG. 30 is a flow chart illustrating a preoperative planning method,according to an embodiment.

FIGS. 31A and 31B illustrate generic and patient-specific components ina surgical kit, according to an embodiment.

DETAILED DESCRIPTION

With reference to FIGS. 1A and 1B a surgical guide 100 is providedaccording to an embodiment. The surgical guide 100 is configured to bemounted to a patient's tibia bone 3 and includes a plurality of modulesto guide various surgical tools used throughout the osteotomy procedure.The surgical guide 100 is patient-specific in that it is designed andmanufactured according to the specific anatomy of a patient. In thisfashion, the surgical guide 100 can be shaped and configured such thatit can fit precisely on a predetermined position on the patient's bone 3and be secured thereto to assure proper alignment of guides for varioussurgical tools. In the present embodiment, the surgical guide 100 has abody made from 3D printed plastic, although it is appreciated that otherbiocompatible materials compatible with other custom manufacturingmethods are also possible.

The body of surgical guide 100 comprises a bone interface side 101 forfacing the patient's bone 3, and an operative side 103 for facing awayfrom the patient's bone 3. In the present embodiment, bone interfaceside 101 is configured to be positioned directly on the patient's bone,and comprises a surface having contours complementary is shape to thesurface contours of a predetermined area of the patient's bone 3. Inthis configuration, bone interface side 101 can abut against thepatient's bone, and key into a specific position thereon. In the presentembodiment, bone interface side 101 comprises a solid surface, howeverit is appreciated that other configurations are possible. For example,the surface can be defined by an open lattice, and can comprise edgesconforming to the contours of the patient's bone 3. Operative side 103is provided opposite interface side 101 and includes a variety ofcomponents for interacting with surgical tools, as will be described inmore detail hereinafter.

In the present embodiment, the body of surgical guide 100 is subdividedinto two separable sections, including a lateral section 105 forsecuring relative to a lateral or medial surface of the patient's bone 3and an anterior section 107 for securing relative to an anterior surfaceof the patient's bone 3. It is appreciated, however, that in otherembodiments, more or fewer sections are possible to secure relative todifferent surfaces of the patient's bone 3 depending on surgicalrequirements. In the present embodiment, lateral section 105 andanterior section 107 are independently securable relative to thepatient's bone 3. In this fashion, the lateral 105 or anterior 107section can be removed from the patient's bone 3 when no longer needed,while the other section can remain secured in place. In the presentembodiment, lateral 105 and anterior 107 sections are secured directlyto the patient's bone, however it is appreciated that in someembodiments, only one of the lateral 105 and anterior 107 need beaffixed directly to the bone. For example, lateral section 105 can beaffixed directly to the bone 3, whereas anterior section 107 can beremovably attached to lateral section 105 such that it is securedrelative the patient's bone 3 without being directly affixed thereto.

In the present embodiment, lateral 105 and anterior 107 sectionscomprise bone-conforming plates secured to the patient's bone 3 viafasteners. The fasteners comprise surgical screws 109 although it isappreciated that other types of fastening mechanisms are also possible.The screws 109 engage in the patient's bone 3 through canals 110 openingon the bone interface 101 and operative 103 sides of the surgical guide100. The canals 110 comprise sidewalls extending along a length forguiding insertion of screws 109 through canals 110 at a specified angleand depth. In this fashion, screws 109 drilled into the patient's bone 3through canals 110 can be guided into a predetermined position,orientation and depth such that they can secure patient-specificsurgical guide 100 to the patient's bone 3 in an optimal fashion, andsuch that the screws 109 will not interfere with tools used duringsubsequent steps during the osteotomy procedure. The sidewalls of canals110 can further be configured to abut against a head of screw 109 toblock the screw 109 from being inserted too deep into the patient's bone3.

In the present embodiment, a plurality of canals 110 are provided forsecuring the surgical guide 100 to the patient's bone 3 via a pluralityof screws 109 at strategic locations. It is appreciated, however, thatin other embodiments, a different number of screws 109 and canals 110can be provided, and that they can be positioned and orienteddifferently depending on the patient's specific anatomy and according tothe planned procedure. Moreover, in the present embodiment, each ofscrews 109 is the same size, but it is appreciated that in otherembodiments, different sized screws can be used to secure differentparts of the surgical guide 100, and that the canals 110 can be sizedand shaped accordingly. Finally, although the screws 109 are guided bycanals 110 in the present embodiment, it is appreciated that otherscrew-guiding mechanisms are possible in other embodiments.

As mentioned above, lateral 105 and anterior 107 sections are separablefrom one another. In the present embodiment, lateral 105 and anterior107 sections are generally disjointed from one another and are connectedvia connecting members. In other words, lateral 105 and anterior 107sections are not directly fused together, and instead comprise separatespaced-apart sections removably secured to one another at a finitenumber of fixed points. In this configuration, each of lateral 105 andanterior 107 sections define two separate bone-contacting surfacesincluding two bone-conforming plates on bone interface side 101 ofsurgical guide 100. It is appreciated, however, that in otherembodiments, lateral 105 and anterior 107 sections can together form asingle coherent surface or plate for contacting the bone 3.

Connecting members 121, 123, can be provided to removably connectdifferent sections of the surgical guide 100. In the present embodiment,the lateral 105 and anterior 107 sections are connected to one anotherat three fixed points via connecting members 121 b, 123 a and 123 b. Theconnecting members 121 b, 123 a, 123 b are stems comprising narrowstrands of rigid material connected at a first end to the lateralsection 105 and at a second end to the anterior section 107. Theconnecting members 121 b, 123 a, 123 b are fused to lateral 105 andanterior 107 sections and/or are formed as integral parts thereof. Inthis fashion, lateral 105 and anterior 107 sections can be rigidlyconnected to one another and can be disconnected by respectivelysevering each of connecting members 121 b, 123 a, 123 b. Connectingmembers 121, 123 are configured such that an intermediate portionthereof is spaced away from surgical guide 100 and/or the patient's bone3, thereby allowing the connecting members 121, 123 to be readilysevered using a severing tool (such as cutting pliers, a saw, orscissors, for example) while minimizing a risk of damaging surgicalguide 100 or bone 3. In the present configuration, connecting members121 b, 123 a, 123 b loop away from the surgical guide 100 and comprise arounded intermediate section spaced away from surgical guide 100.Although a particular configuration of connecting members 121, 123 hasbeen shown, it is appreciated that other configurations are possible. Inother embodiments, connecting members 121, 123 can have differentshapes, and can include different connecting elements. For example, insome embodiments, instead of being fused and/or an integral part oflateral 105 and/or anterior 107 sections, connecting members 121, 123can be separate pieces removably engageable in lateral 105 and/oranterior 107 sections. As can be further appreciated, in otherembodiments, a different number of connecting members 121, 123 can beprovided, and they can be positioned differently.

As mentioned above, the surgical guide 100 comprises a plurality ofmodules to guide various surgical tools used throughout the osteotomyprocedure. Each module can perform a different function for assistingwith various tasks throughout an osteotomy procedure. Some modules canform integral parts of the lateral 105 and/or anterior 107 sectionssecured directly to the patient's bone 3, whereas other modules can beindependent elements which can be secured to relative to the patient'sbone 3 by attaching to lateral 105 and/or anterior 107 sections.Although a particular set of modules will be described in detailhereinafter, it is appreciated that other modules and combinationsthereof are possible depending on the requirements of the surgicalprocedure. Moreover, although some modules are described as performingparticular functions, it is appreciated that some modules can performtwo or more functions and/or have other advantages or uses notexplicitly described herein, but that would be readily understood by aperson of skill in the art upon reading the present disclosure.

Security Pin Guide Module

In the present embodiment, a security pin guide module is provided forguiding insertion of a corresponding security pin or rod 111 into thepatient's bone 3. Security pin guide module is an integral part of bodyof surgical guide, and comprises a security pin guide 112 formedtherein. More specifically, security pin guide 112 is provided onanterior section 107 of surgical guide 100, although it is appreciatedthat other configurations are possible. In the present embodiment,security pin guide 112 is positioned proximate a top portion of anteriorsection 107 and comprises a canal to guide an angle of security pin 111as it is inserted into the patient's bone 3. The pin guide 112 is angledsuch that when the security pin 111 is inserted into the patient's bone3 it runs parallel to the tibial plateau. The security pin 111 is madefrom a rigid, biocompatible material, such as stainless steel ortitanium, and can be screwed into the patient's bone 3. Once insertedinto the patient's bone 3, the security pin 111 can remain in place forthe remainder of the osteotomy procedure to protect the tibial plateaufrom fracturing. Accordingly, the security pin guide module can beconfigured to be removable from security pin 111 once the security pin111 is installed. For example, pin guide 112 can be configured such thatsecurity pin 111 can slide therethrough unobstructed, allowing pin 111to slide out from pin guide 112 when the security pin guide module isremoved, for example when the anterior section 107 is removed from thepatient's bone 3. Other configurations of pin 111 and pin guide 112 arealso possible.

Drilling Module

A drilling module 113 is provided to assist in creating drill holes 116in the patient's bone 3 in preparation for forming a cut therein. In thepresent embodiment, the drilling module 113 is removably secured to thebody of surgical guide 100 via connecting members 121. Morespecifically, a plurality of connecting members 121 a, 121 b, and 121 cextend between the drilling module 113 and the body of surgical guide100, securing the drilling module 113 to lateral 105 and anterior 107sections of surgical guide 100. The connecting members 121 comprisestems of rigid material forming integral parts of both surgical guide100 and drilling module 113, and drilling module 113 can be removed fromsurgical guide 100 by severing stems of connecting members 121.

Although in the present embodiment the drilling module 113 is secured tothe body of surgical guide 100 via severable stems, it is appreciatedthat other connection mechanisms are possible to secure and positiondrilling module 113 relative to the patient's bone. For example,drilling module can engage with body of surgical guide 100 viafasteners, and/or can engage directly to the patient's bone. In anembodiment, for example as shown in FIG. 9 , the drilling module 113 canclip onto a predetermined position on surgical guide 100. In theembodiment of FIG. 9 , surgical guide 100 a comprises a drill moduleinterface 131 in the form of a tongue element. A corresponding removabledrill guide module, such as drill guide modules 113 a and 113 b shown inFIGS. 10A and 10B, can comprise a slot or groove sized and shaped toreceive tongue 131 therein. In this configuration, drill guide module113 a, 113 b can clip onto a fixed position on surgical guide 100 bysliding over tongue 131. It is appreciated that in alternateembodiments, drill guide 113 can comprise a tongue for fitting in acorresponding groove in surgical guide 100 and/or a combination oftongue and grooves for fitting with corresponding tongue and groves insurgical guide 100.

Referring back to FIGS. 1A and 1B, the drilling module 113 comprises aplurality of drill guides 115 for cooperating with corresponding drillbits to guide a position, depth, and angle thereof to form drill holes116 in the patient's bone 3 in a predetermined configuration. In thepresent embodiment, the drill guides 115 each comprise a guiding elementaccessible from the operative side 103 of surgical guide 100. Theguiding element comprises a guide barrel 120 extending from theoperative side 103 of surgical guide 100, although it is appreciatedthat other types of guide elements are also possible. The guide barrel120 extends along a lengthwise axis, between a proximal end proximatethe bone interface side 101 of guide 100, and a terminal end 124 on theoperative side 103 of guide 100. The guide barrel 120 comprisessidewalls defining a hollow interior in the form of a guide tunnel 122extending through the guide barrel 120 along the lengthwise axisthereof, and opening on the bone interface side 101 and operative side103 of guide 100. The guide tunnels 122 are sized and shaped to receivea corresponding drill bit therein, allowing the drill bit to slide inand out of barrel 120, while sidewalls of barrel 120 constrain movementof the drill bit to a predetermined depth, position, and orientationrelative to the patient's bone.

With reference to FIG. 2 , a drill bit 200 configured to cooperate withdrill guide is shown according to an embodiment. The drill bit 200comprises a drill bit body 201 extending along a length, and terminatingat a cutting end 202. A depth guide 203 is provided on the drill bitbody 201 and spaced away from the cutting end 202, effectively definingan operative length 205 of drill bit 200. In the present embodiment,depth guide 203 is removably secured to drill bit body 201 via fastener204, allowing operative length 205 of drill bit 200 to be adjusted byloosening fastener 204 and sliding depth guide 203 to a desired locationalong the length of the drill bit body 201. It is appreciated, however,that in other embodiments, depth guide 203 can be permanently affixedto, and/or form an integral part of, drill bit body 201, effectivelydefining a fixed predetermined operative length 205. For example, asshown in FIG. 2A, drill bits 200 a, 200 b, 200 c and 200 d havingrespective fixed lengths of 80 mm, 90 mm, 100 mm and 110 mm are shown.Each drill bit comprises a depth guide 203 permanently secured relativeto cutting end 202. As can be appreciated, a collection of fixed drillbits can be provided as part of a kit, and each bit can be identifiedvia markings, and/or via color coding. In some embodiments, the markingsand/or color coding can match with corresponding marking and/or colorcoding on the drill guides 115 in the drilling module 113.

With reference now to FIGS. 1A, 1B, 2 and 2A, depth guide 203 comprisesan abutment member 206 for limiting an insertion depth of drill bit 200in guide barrel 120. When operative length 205 of drill bit 200 is fullyinserted into guide barrel 120, the abutment member 206 abuts againstterminal 124, effectively preventing further insertion of drill bit 200.As can be appreciated, in this configuration, drill bit 200 can only beinserted into guide barrel 120 at a fixed insertion depth 118 relativeto the terminal end 124. The position of terminal end 124 relative tothe patient's bone 3 thus defines the penetration depth of drill bit 200into the patient's bone 3. Accordingly, the length of guide barrel 120determines the bone penetration depth of drill bit 200: a longer guidebarrel 120 results in a shallower bone penetration depth of drill bit200, and a shorter guide barrel results in a deeper bone penetrationdepth. Similarly, the position and orientation of the guide barrel 120defines the position and orientation at which the drill bit 200penetrates the patient's bone 3.

In the present embodiment, a plurality of drill guides 115 are providedfor cooperating with a calibrated drill bit 200 having a fixed operativelength 205. The drill guides 115 comprise guide barrels 120 positionedand arranged to create drill holes 116 in a predefined pattern to weakenthe patient's bone 3 in preparation for a planar cut. More specifically,the drill guides 115 are positioned and oriented in a co-planar,parallel arrangement to define parallel drill holes 116 in the patient'sbone 3 in a common plane 133. The guide barrels 120 of drill guides 115are sized based on the specific geometry of the patient's bone 3, suchthat the drill holes 116 cover a majority of a cross section of thepatient's bone 3, while leaving a non-weakened section to eventuallyform a hinge along which the patient's bone 3 can be opened. Morespecifically, the guide barrels 120 are positioned such that drill holesdefine a hinge axis 9 at a border between weakened and non-weakenedareas of the patient's bone 3 in the common plane 133. As can beappreciated, hinge axis 9 can be oriented depending on the type andposition of opening to be formed in the patient's bone 3 as determinedaccording to a preoperative plan, to correct the mechanical axis of thepatient's bone 3 as needed. In the present embodiment, hinge axis 9 is astraight line, but it is appreciated that other shapes are alsopossible.

Although in the present embodiment the drilling module 113 is configuredto create drill holes 116 in a parallel orientation, it is appreciatedthat in other embodiments, the drilling module 113 can be configuredsuch that some or all drill holes do not run parallel to one another.For example, the drill holes 116 can be grouped into two or morearrangements which intersect with one another. Although different groupsof drill holes can be guided by the same drilling module 113, it isappreciated that in some embodiments, two or more drilling modules 113can be provided, for example to create drill holes 116 in differentarrangements, to weaken the patient's bone 3 in different steps/stages,and/or to allow drill bits to be inserted at different angles ofapproach. Where a plurality of drilling modules 113 are provided, theycan be positioned and/or attached on the same section of the guide 100,or can be positioned on different sections of the guide 100, for exampleto drill on different faces of the patient's bone 3 and/or allow drillbits to be inserted at different orientations, for example to facilitatedrilling holes in a position which would otherwise be more difficult toaccess.

For example, as shown in FIGS. 9, 10A, 10B, 11A, and 11B, surgical guide100 a can be configured with an anterior section 107 having a drillmodule interface 131 for connecting one or more removable drill modules113 thereto. A first drilling module 113 a can be attached thereto toguide drill bits 200 to form drill holes 116 in a first parallelorientation 133 a in the common plane 133 in the patient's bone. Thefirst drilling module 113 a can subsequently be removed, and in itsplace a second drilling module 113 b can be attached to the sameposition on anterior section 107 via drill module interface 131. Thesecond drilling module 113 b can then guide drill bits 200 to form drillholes 116 in a second parallel orientation 133 b different from thefirst parallel orientation 133 a, and in the same plane 133. As can beappreciated, the two drilling modules 113 a, 113 b can allow forweakening the patient's bone 3 along the plane 133 in two phases and byinserting drill bits 200 at different orientations. This can, forexample, allow a complete area of the patient's bone 3 to be weakened inpreparation for cutting the patients bone, while reducing the size ofthe tissue incision required to access the patient's bone 3 to performthe procedure.

Finally, although in the presently described embodiments the drillingmodule 113 is configured to guide drill holes 116 in a common plane 133,it is appreciated that in other embodiments, the drilling module can beconfigured to guide drill holes 116 into two or more planes depending onthe requirements of the surgical procedure. For example, with referenceto FIGS. 12A, 12C, and 12D drilling module 113 can comprise a firstgroup of parallel drill guides 115 a for creating drill holes 116 in afirst plane 133, and a second group of parallel drill guides 115 b forcreating drill holes 116 in a second plane 135. As can be appreciated,the first plane 133 is not parallel to second plane 135 and issubstantially perpendicular thereto, allowing to weaken the bone 3 toeventually form a biplanar cut 5 a, 5 b therein.

As can be appreciated, in some embodiments, a single drilling module 113can be configured to create all the necessary drill holes to weaken thebone 3 in planes 133, 135 in preparation for forming biplanar cuts 5 a,5 b. However, in other embodiments, two or more drilling modules 113 canbe provided to create the necessary drill holes in planes 133, 135 inphases. For example, in the embodiment shown in FIGS. 12A, 12B, 12C, and12D, two drilling modules 113 a and 113 b are provided. A first drillingmodule 113 a can be secured to drilling module interface 131 to createdrill holes 116 in the first plane 133 in a first parallel orientation133 a. The drilling module 113 a includes a cover element 137 forcovering openings in the drilling module interface 131 extending alongthe direction of the second plane 135. Once the drill holes have beenformed in the first plane 133, the drilling module 113 a can be removed,and a second drilling module 113 b can be secured to the drilling moduleinterface 131. The second drilling module 113 b is provided with a firstgroup of drill guides 115 a for drilling holes 116 in the first plane133 in a second parallel orientation 133 b different from the firstparallel orientation 133 a, thereby completing the required weakening ofthe bone in the first plane 133. The second drilling module 113 b isfurther provided with a second group of drill guides 115 b for drillingholes 116 in the second plane 135. In the present embodiment, the secondgroup of drill guides 115 b in the second drilling module 113 b aresufficient to weaken the bone to form the second planar cut 5 b. It isappreciated, however, that in other embodiments, further drill guidescan be provided to cut in the second plane 135 in different parallelorientations.

Although in the embodiment described above, modules 113 a and 113 b aredescribed as “first” and “second” modules, it is appreciated that theirorder of use can be inversed depending on the requirements of thesurgical procedure. Moreover, although two modules were described, it isappreciated that in other embodiments, subsequent modules can beprovided to further weaken the bone via drill holes 116 in differentparallel orientations and/or in different planes as required. Moreover,in some embodiments, a cover element can be provided to cover opening inthe drilling module interface 131 extending along the direction of thefirst plane 133, for example in a drilling module configured to drillholes only in the second plane 135.

Cutting Module

Referring back to FIGS. 1A and 1B, a cutting module 117 is provided toassist in cutting the patient's bone 3. In the present embodiment, thecutting module 117 comprises an osteotome guide 127 for guiding acorresponding osteotome to cut the patient's bone 3 at predeterminedposition, orientation and depth. The guide 127 is configured to guideosteotome to create a planar cut in the patient's bone 3 in the areaweakened by the drill holes 116 formed using the drilling module 113.The cutting module 117 is provided in anterior section 107 of guide 100,and is affixed directly to the patient's bone via fasteners 109. It isappreciated, however, that in other embodiments, the cutting module 117can be removably attached to the lateral 105 and/or anterior 107sections of the surgical guide 100.

Although in the present embodiment a single cutting module 117 is shown,it is appreciated that two or more cutting modules can be provided inother embodiments. For example, in some embodiments, two or more cuttingmodules can be provided to help create a single planar cut in two ormore stages. In some embodiments, a first cutting module can beconfigured to create a first planar cut in a first direction, and asecond cutting module can be configured to create a second planar cut ina second direction. The cutting modules can be permanently or removablyaffixed relative to the same area of the patient's bone 3, and/or can beremovably or permanently affixed relative to different areas of thepatient's bone 3, for example to access the bone 3 from differentpositions.

The osteotome guide 127 comprises a body extending between abone-contacting end on the bone interface side 101 of surgical guide100, and a terminal end on operative side 103 of surgical guide 100. Thebody has a planar aperture or slot 129 extending therethrough andopening on the bone-contacting end and the terminal end. The slot 129 issized and shaped to receive a corresponding osteotome therein, and toguide the osteotome to cut the patient's bone 3 at a position, angle,and depth corresponding to the area of the patient's bone 3 weakened bythe drilling module 113. More specifically, osteotome can slide in andout of slot 129, while sidewalls around the aperture constrict themovement of osteotome to the correct position and angle to form thedesired cut. Similarly, an abutting member of osteotome is configured toabut against terminal end of the osteotome guide 127 to limit aninsertion depth of the osteotome. As can be appreciated, osteotome guide127 can have visual indications provided thereon to further help guideosteotome visually and/or to indicate a type of osteotome to be usedwith guide 127.

In the present embodiment, in order to guide the osteotome to cut thearea of the patient's bone 3 weakened by drilling module 113, theosteotome guide 127 is positioned in alignment with the drill guides115. More specifically, the cutting module 117 is positioned adjacentthe patient's bone 3, and the drilling module 113 is positioned adjacentthe cutting module 117, such that the drill guides 115 open in alignmentwith the slot 129 in the osteotome guide 127. In this configuration,drill guides 115 guide drill bits 200 through the slot 129 in osteotomeguide 127 before entering the patient's bone 3, thereby assuring thatdrill bits 200 and osteotome operate in the same plane 133. In thepresent configuration, cutting module 117 is affixed directly topatient's bone 3, while drilling module 113 is removably attached tocutting module 117. Drilling module 113 can thus be removed after drillholes 116 have been formed, providing the osteotome with direct accessto cutting module 117. It is appreciated that other configuration arepossible which can still allow brill bits 200 and osteotome to operatein the same plane. For example, in some embodiments, both drillingmodule 113 and cutting module 117 can be removably attachable tosurgical guide 100. Drilling module 113 can be attached first to createddrill holes 116. Drilling module 113 can be subsequently removed, andcutting module 117 can be attached to the same are of guide 100 asdrilling module 113, allowing cutting module 117 to guide the osteotomein the same plane as the drill holes 116.

In the present embodiment, the cutting module 117 is configured to guideosteotome to create a single planar cut 5 in the patient's bone 3,however it is appreciated that in other embodiment, the guide can beconfigured to create two or more cuts and/or cuts having a contour orcurve. For example, with reference to FIGS. 12A and 12C, surgical guide100 b comprises an osteotome guide 127 configured with first 129 a andsecond 129 b slots for guiding osteotome to cut the patient's bone tocreate two planar cuts 5 a and 5 b along two different planes 133, 135.As can be appreciated, although two slots 129 a and 129 b are provided,use of the second slot 129 b can be optional, allowing the same guide100 b to be compatible with both procedures involving single planar cuts5 and biplanar cuts 5 a, 5 b. For example, as shown in FIG. 12D, adrilling module 113 a can be provided which includes drill guides 115 inonly the first plane 133, whereas a cover element 137 covers the slots129 b in the second plane 135. In this fashion, the bone is onlyweakened along the first plane 133, and cut 5 a can be formed in saidplane. Additionally or alternatively, when manufactured for suchprocedures, the slot 129 b in guide 100 b can be covered to prevent anosteotome from being inserted therein. As can be appreciated, the guide100 b can still include the section of tongue of drill module interface131 which extends along the plane where slot 129 b once extended. Inthis fashion, the shape of drilling module interface 131 can be the sameregardless of whether or not a second plane is to be cut. This can allowfor the same general shape/configuration of surgical guide 100 b to beused for different types of surgical procedures involving single orbiplanar cuts, and similarly allows for the same generalshape/configuration of drill modules 113 to be used. This can simplifythe manufacturing and design of surgical guide 100 and correspondingmodules, as the same shape can be used for all procedures types, yetsimply adapted to conform the anatomy of the patient's bone 3.

Anchor Module

With reference now to FIG. 3A, an anchor module 119 is provided toanchor removable modules relative to the patient's bone 3. In thepresent embodiment, anchor module 119 is provided in the lateral section105 of the surgical guide 100, but it is appreciated that in otherembodiments, anchor module 119 can be provided in a different section ofguide 100. Moreover, in some embodiments, a plurality of anchor modulescan be provided. The anchor module 119 is affixed directly to thepatient's bone 3 via fasteners 109 and comprises a removable moduleinterface 128 for interfacing with removable modules. The anchor modulecan thus act as a secure base to which other modules can be removablyattached, allowing the removable modules to be properly aligned relativeto the patient's bone 3 at relevant steps during the surgical procedure.In the present embodiment, the removable module interface 128 comprisesapertures for receiving corresponding protrusions extending from aremovable module, although it is appreciated that other removableconnection interfaces are possible.

In the present embodiment, the anchor module 119 comprises two sectionsfor providing two distinct anchoring points. More specifically, theanchor module 119 comprises a proximal section 125 a positionedproximate the joint between the patient's femur 1 and tibia 3 bones, anda distal section 125 b spaced further away from the joint between thefemur 1 and tibia 3. The proximal 125 a and distal 125 b sections areseparable from one another, allowing them to move independently whilebeing secured to different sections of the patient's bone 3. In thepresent embodiment, proximal 125 a and distal 125 b sections are securedto one another via connecting member 126. The connecting member 126 canbe severed to separate proximal 125 a and distal 125 b sections andallow them to move independently with different sections of bone. Forexample, in the present embodiment, proximal 125 a and distal 125 bsections are positioned on the patient's bone 3 on opposite sides of theplanar cut formed by drilling module 113 and cutting module 117. Afterthe planar cut is formed, connecting member 126 can be severed toseparate proximal 125 a and distal 125 b sections. The bone 3 can beopened along the planar cut, with the proximal 125 a and distal 125 bsections moving away from one another while being respectively connectedto the bone 3 above and below the opening formed in the bone 3. In thisfashion, the proximal section 125 a can provide an anchoring point aboveor proximal the opening in the bone 3, while the distal section 125 bprovides an anchoring point below or distal the opening in the bone 3.It is appreciated that other positions and configurations of anchormodule 119 and corresponding sections are possible, depending on thesurgical procedure. It is further appreciated that the separablesections of anchor module 119 can be connected to one another viadifferent removable connection mechanisms.

Predrilling Module

With reference to FIGS. 3A and 3B, a predrilling module 300 is providedfor predrilling holes in the patient's bone 3 for eventually receivingfasteners to secure a plate or other implant to the patient's bone 3.The predrilling module 300 is patient-specific in that it is custom madeaccording to the anatomy of the patient's bone 3 and according to apreoperative plan. In this fashion, the predrilling module 300 can beconfigured to precisely fit on a predetermined position of the patient'sbone 3 to assure proper alignment, and to assist in drilling holes inthe patient's bone 3 in predetermined positions, orientations anddepths.

In the illustrated embodiment, the predrilling module 300 comprises abody 302 having a bone interface side 301 and an operative side 303. Thebone interface side 301 comprises a bone-contacting surface havingcontours complementary in shape to the surface contours of the patient'sbone 3. In this configuration, bone interface side 301 can abut againstthe patient's bone 3, and key into a specific position thereon. In thepresent embodiment, bone interface side 301 comprises a solid surface,however it is appreciated that other configurations are possible. Forexample, the surface can be defined by an open lattice, and can compriseedges conforming to the contours of the patient's bone 3.

The operative side 303 is provided opposite the bone interface side 301and comprises a plurality of drill guides 307 extending therefrom forguiding corresponding drill bits. In the present embodiment, the drillguides 307 each comprise a guide barrel 309 extending from the body ofthe predrilling module 303 at a predetermined angle along a lengthwiseaxis and terminating at a terminal end 314. The guide barrel 309comprises sidewalls defining a hollow interior in the form of a guidetunnel 311 extending through the guide barrel 309 along the lengthwiseaxis thereof and opening on the bone interface side 301 and operativeside 303 of predrilling module 303. The guide tunnels 311 are sized andshaped to receive a corresponding drill bit therein, allowing the drillbit to slide in and out of barrel 309, while sidewalls of barrel 309constrain movement of the drill bit to a predetermined depth, position,and orientation relative to the patient's bone 3. An abutting member onthe drill bit can limit an insertion depth of an operative end of thedrill bit into the barrel 309 as it abuts with terminal end 314 of guidebarrel 309. As can be appreciated, in this configuration, the length ofbarrel 309 can limit insertion depth of a drill bit and assure the depthof drill holes formed therewith.

The plurality of drill guides 307 are configured to cooperate with acalibrated drill bit having a fixed operative length. The guide barrels309 of the drill guides 307 are sized, positioned and oriented to createdrill holes 308 in a predefined pattern for receiving fasteners tosecure an implant, such as plate, to the patient's bone 3. As will bedescribed in more detail hereinafter, the implant to be secured can bepatient-specific and can be designed to be affixed using different typesof fasteners. Based on the anatomy of the patient's bone 3, apreoperative plan can define a configuration of fasteners, includingsize, depth, orientation, and position, such that the implant can beaffixed optimally. The drill guides 307 can thus be configured to guidedrill bits to form drill holes 308 in preparation for receiving theconfiguration of fasteners defined in the preoperative plan. Forexample, the length of each guide barrel 309 can be adjusted to limitthe insertion depth of the drill bit, creating drill holes 308 withdifferent predetermined depths. Similarly, the position an orientationof guide barrels 309 can be adjusted to define drill holes 308 whichextend at different angles and positions. Finally, diameters of guidetunnels 311 can be adjusted to accommodate drill bits of differentdiameters to create drill holes of different sized for accommodatingdifferent sizes of fasteners.

In the present embodiment, the predrilling module 300 is configured topredrill holes 308 in the patient's bone 3 prior to a surgicalalteration of the bone's geometry. The predrilling module 300 is thusconfigured to account for the drill holes 308 moving as the geometry ofthe bone is altered during surgery, such that the drill holes 308 willbe in alignment with the fasteners of an implant once the bonealterations are complete. For example, in the context of a high-tibialopen-wedge osteotomy procedure, the predrilling module 300 can beconfigured to predrill holes while the patient's bone 3 is in a closedconfiguration (i.e. before the patient's bone 3 is opened along theplanar cut formed using the drilling 113 and cutting 117 modules). Inthis configuration, the guide barrels 309 are positioned to form drillholes 308 which will eventually align with the location of fasteners foraffixing an implant once the patient's bone 3 is opened along the planarcut to an opened configuration. As can be appreciated, the requiredposition of drill holes 308 can be determined by modelling the patient'sbone 3, virtually opening the bone model to a desired opening angle, andvirtually positioning an implant and corresponding fasteners on the bonemodel to set final positions of the drill holes 308. The bone model canbe subsequently closed virtually to determine corresponding initialpositions of the drill holes 308. The predrilling module 300 can then bedesigned according to the initial positions of the drill holes 308.

As shown in FIGS. 3A and 3B, predrilling module 300 comprises anattachment/alignment mechanism 305 for securing the predrilling module300 relative to the patient's bone 3 and/or for assuring properalignment of the predrilling module 300 relative to the patient's bone3. In the present embodiment, the attachment/alignment mechanism 305comprises an attachment interface for interfacing with removable moduleinterface 128 in anchor module 119. The attachment/alignment mechanisms305 is configured such that the predrilling module 300 can attach toanchor module 119 in only one position/orientation, thus assuring thatpredrilling module 300 is properly aligned once it is attached to anchormodule 119. For example, in the present embodiment, the attachmentinterface comprises two protrusions or pins 306 sized and shaped toengage in corresponding apertures in anchor module 119. The protrusions306 provide two fixed attachment points which must be respectively alignwith two fixed anchoring points in the anchor module 119 for thepredrilling module 300 to engage with anchor module 119. In the presentembodiment, the protrusions 306 are positioned to align with anchormodule 119 while the patient's bone 3 is in a closed configuration,thereby allowing the predrilling module 300 to engage with the patient'sbone 3 and predrill holes 308 prior to opening the bone 3 (i.e. theprotrusions 306 respectively align with the proximal 125 a and distal125 b sections while they are adjacent one another). It is appreciatedthat in other embodiments, the protrusions 306 can be positioned toalign with the anchor module 119 when the patient's bone is in theopened configurations (i.e. when the proximal 125 a and distal 125 bsections are space apart from one another across the opening in thepatient's bone 3).

Although in the present embodiment a single mechanism 305 provides boththe functions of securing and aligning predrilling module 300 relativeto the patient's bone 3, it is appreciated that in other embodiments,different mechanisms can be provided to align and/or to securepredrilling module 300, and that separate mechanisms can be provided torespectively perform the alignment or attachment functions. For example,in some embodiments, predrilling module 300 can be secured to thepatient's bone directly via fasteners. In some embodiments, the boneinterface side 301 of predrilling module 300 can be shaped to havecontours complementary in shape to the contours of a specific area ofthe patient's bone 3. In some embodiments, mechanism 305 can comprise amember configured to interface and/or insert into a hole or otherfeature formed in the patient's bone 3, for example in the openingformed along the planar cut.

The predrilling module 300 further comprises a handle member 313 whichallows the module 300 to be more easily manipulated and positioned. Inthe present embodiment, the handle member 313 is a rigid elongatedmember extending from the body of the predrilling module 300 along alengthwise axis and facilitates manipulation of the module 300 by hand.It is appreciated that in other embodiments, different types of handlemembers can be provided. For example, handle member can be removableand/or can comprise an interface for a positioning tool or guide. In thepresent embodiment, the handle member 313 has inscriptions providedthereon to identify the predrilling module 300 and/or to indicate thetype of drill bits with which the predrilling module 300 is designed tocooperate.

Although in the illustrated embodiment the predrilling module 300 isconfigured to drill holes 308 prior to a change in the geometry of thepatient's bone 3, it is appreciated that the predrilling module 300 canbe configured differently according to the requirements of the surgicalprocedure. For example, as shown in FIG. 13 , an embodiment of apredrilling module 300 a is shown in which the module 300 a isconfigured to drill holes 308 after the geometry of the patient's bone 3has been surgically altered. In this embodiment, the predrilling module300 a is configured to span across opening 7 formed in the patient'sbone 3, and position drill guides 307 to define drill holes 308 directlyin their final position. More specifically, the predrilling module 300 ahas a body 302 substantially similar to a fixation plate which willultimately be used to secure the opening 7 in the patient's bone 3. Thebone 3 can thus be opened along planar cut 5 to form opening 7, and oncethe opening 7 is formed, the predrilling module 300 can be secured tothe bone at the same position where the fixation plate will eventuallybe attached. The predrilling module 300 will thus have its drill guides307 positioned exactly where the fastener apertures of fixation platewill eventually be positioned. Therefore, after drill holes 308 areformed, predrilling module 300 can be removed and replaced with fixationplate. Fixation plate can be positioned to align with the holes 308 andthen secured in place via fasteners.

In the present embodiment, the body 302 of predrilling module 300 has abone interface side 301 having a bone-contacting surface substantiallyconforming to a surface contour of the patient's bone 3 at apredetermined position. The body 302 is configured with a proximalsection 302 a for positioning adjacent a surface of the patient's bone 3above opening 7, a distal section 302 b for positioning adjacent asurface of the patient's bone 3 below opening 7, and an intermediatesection 302 c for spanning the opening 7. The attachment/alignmentmechanism 305 comprises a wedge extending from bone interface side 301on the intermediate section 302 c of body 302, and configured to beinserted into the opening 7. As can be appreciated, wedge 305 can besized and shaped according to the expected dimensions of the desiredopening 7 according to a preoperative plan. It can further comprisecontours matching inner surface contours of the opening 7, as will bedescribed in more detail below in connection with the opening validator.The wedge 305 can thus allow predrilling module 300 to secure at apredetermined position relative to opening 7, while also validating thatthe bone 3 has been opened to the correct angle. Once module 300 hasbeen correctly positioned, it can be secured in place relative to thepatient's bone 3 before drilling is performed through drill guides 307.In the present embodiment, the body 302 comprises fastener apertures 312a, 312 b in the proximal 302 a and distal 302 b sections to allow thebody 302 to be secured directly to the patient's bone 3 via fasteners.It is appreciated, however, that other attachment mechanism arepossible. For example, the module 300 could secure to an anchor modulealready attached to the patient's bone 3 at the correct position.

Spreader Module

With reference now to FIGS. 4, 4A and 4B, a spreader module 400 (orspreading tool) to assist in spreading the patient's bone 3 is shownaccording to an embodiment. In the present embodiment, the spreadermodule 400 is configured to open the patient's bone 3 along a planar cut5 formed therein. The planar cut 5 is opened at an angle about a hinge9, thereby defining an open wedge 7 in the patient's bone. The spreadermodule 400 is configured to operate in cooperation with anchor module119 secured to the patient's bone 3, but it is appreciated that otherconfigurations are possible. As can be appreciated, the spreader module400 can be a generic tool, and need not be custom made according to thepatient. Instead, the surgical guide 100 can be designed to cooperatewith generic spreader module 400. Accordingly, spreader module 400 canbe made out of any rigid material, according to any manufacturingprocess. However, it is appreciated that in some embodiments, thespreader module 400 can be custom designed for the patient and toconform to a specific geometry of the guide 100. In such embodiments,the spreader module 400 can be made from materials suitable for custommanufacturing, for example from the same 3D printed plastic from whichthe surgical guide 100 and corresponding modules are made.

In the present, spreader module 400 comprises an upper arm 402 a and alower arm 402 b pivotally connected to one another via a hinge 407. Ascan be appreciated, spreader module 400 is generally configured as adouble lever, with an effort end 401 and a load end 403, and hinge 407acting as a fulcrum therebetween. More specifically, as effort ends 401a, 401 b of upper and lower arms 402 a, 402 b are moved towards oneanother, upper and lower arms 402 a, 402 b pivot about hinge 407 causingload ends 403 a, 403 b to move away from one another. In other words, aforce applied at effort end 401 causing ends 401 a and 401 b to convergeis transferred to load end 403, causing load ends 403 a and 403 b toseparate. It is appreciated that other configurations of spreader module400 are possible, so long as it permits a separating force to be appliedto load ends 403 a and 403 b. For example, in some embodiments, thespreader module 400 can be configured such that a spreading of effortends 401 a, 401 b transfers a spreading force to load ends 403 a, 403 b.In other embodiments, different types of spreading mechanisms arepossible.

In the present embodiment, force on effort end 401 is applied via a handwheel 409. As wheel 409 is operated, screw mechanism 411 rotates andengages in threaded bores in effort ends 401 a, 401 b, thereby drawingeffort ends 401 a, 401 b together or spreading them apart depending onthe rotating direction of screw 411. As can be appreciated, in thisconfiguration, a rotational force applied to wheel 409 is converted intoa linear force which draws effort ends 401 a, 401 b together or spacesthem apart. Moreover, the rotational force applied to and wheel 409merely causes a change in spacing of effort ends 401 a, 401 b. Aconstant force does not need to be applied to wheel 409 to retain effortends 401, 401 b at a fixed spacing; instead, when no force is applied,the engagement of screw mechanism 411 retains arms 402 of spreadermodule 400 at their current angle, retaining effort ends 401 a, 401 b ata fixed spacing until force is applied to wheel 409. Spacing of effortends 401 a, 401 b can thus be precisely controlled by hand, via smalland/or measured rotational movements of hand wheel 409. It isappreciated, however, that a force controlling spacing of effort ends401 a, 401 b can be applied via different mechanisms, and that suchmechanisms need not necessarily be operated by hand. For example, insome embodiments, force can be applied via hydraulics or motors, and/orcan be controlled electronically.

As mentioned above, spreader module 400 is configured to cooperate withanchor module 119 secured to the patient's bone 3. Spreading module 400comprises an anchor interface 405 at load end 403 for interfacing withanchor 119 and transferring spreading force thereto. More specifically,in the present embodiment, the anchor interface 405 comprisesprotrusions or pins sized and shaped to engage in correspondingapertures in anchor module 119. A protrusion or pin at load end 403 a ofupper arm 402 a is positioned to engage with proximal section 125 a ofanchor module 119, whereas a protrusion or pin at load end 403 b orlower arm 402 b is positioned to engage with distal section 125 b ofanchor module. In this configuration, arms 402 a, 402 b of spreadermodule independently engage in the distinct anchoring points 125 a, 125b, allowing arms 402 a, 402 b to apply a spreading force thereon inopposite directions, and move anchoring points 125 a, 125 b away fromone another.

In the present embodiment, the protrusions or pins extend from arms 402a, 402 b substantially perpendicular therefrom, and along an axissubstantially parallel to the pivot axis of hinge 407. As can beappreciated, in this configuration, spreader module 400 can engage withanchor 119 by sliding protrusions or pins of anchor interface 405laterally into the corresponding apertures of anchor 119. A verticalspreading force can be subsequently applied to arms 402 a, 402 b withoutcausing interface 405 to disengage. In the same manner, spreader module400 can be easily disengaged from anchor 119 by sliding the protrusionsor pins out along the lateral direction. As can be further appreciated,in this configuration, spreader module 400 can engage with anchor module119 and operate along the lateral section of the patient's bone 3,leaving anterior section of the bone 3 clear so as to not interfere withsubsequent steps in the surgical procedure. Apertures in anchor module119 open on both anterior and lateral sides thereof, allowing thespreader module 400 to engage on either the anterior or lateral side ofanchor module 119 depending on the requirements of the surgicalprocedure. It is appreciated, however, that in other embodiments,spreader module 400 can engage on other sides of anchor module 119, suchas on its front side, and/or on top/bottom sides.

In the present embodiment, pins or protrusions of anchor interface 405are substantially cylindrical and engage in substantially circularapertures in anchor module 119. As can be appreciated, in thisconfiguration, pins or protrusions can rotate freely inside apertures ofanchor module 119, allowing relative angular displacement of ends 403 a,403 b relative to anchoring points 125 a, 125 b while engaged therein.It is appreciated, that in other embodiments, anchor interface 405and/or anchor module 119 can comprise different engagement mechanisms.For example, in some embodiments, anchor interface 405 can be secured toanchor module 119 via fasteners. In some embodiments, ends 403 a, 403 bcan key into anchoring points 125 a, 125 b at specific relativeorientations, and/or pins or protrusions can be pivotally secured toends 403 a, 403 b of arms 402 a, 402 b.

Spreader module 400 is operable to move between a closed configuration400 a and an opened configuration 400 b. In the closed configuration 400a, anchor interface 405 on load ends 403 a, 403 b are substantiallyproximate one another and aligned with anchoring points 125 a, 125 bprior to spreading the patient's bone 3. In the opened configuration 400b, anchor interface 405 on load ends 403 a, 403 b are spaced apart fromone another, and load end 403 a, 403 b are angled relative to oneanother at an opening angle. In the present embodiment, a gauge 413 isprovided to indicate the magnitude of opening angle. The gauge 413comprises a scale affixed to upper arm 402 a, and movable through acorresponding aperture in lower arm 402 b. A window 415 in lower arm 402b provides a visual indicator for reading scale. It is appreciated,however, that other gauge mechanisms are possible to indicate themagnitude of opening angle. In the present embodiment, gauge 413 iscalibrated such that scale is zeroed when the spreader module 400 is inthe closed configuration 400 a. The opening angle indicated by gauge 413can thus provide an accurate and precise indication of the opening angleof spreader module 400. In some embodiments, the gauge 413 can befurther calibrated such that it corresponds to the opening angle abouthinge 9 in patient's bone 3. In this configuration, the gauge canprovide a precise and accurate indicate of opening angle of the openwedge 7 formed in the patient's bone, as the bone is opened along cut 5using spreader module 400.

Although the module 400 is referred to herein as a “spreader” module, itis appreciated that it can be used not only to spread the patient's bone3, but also to contract the patient's bone 3, for example as part of aclosed-wedge osteotomy. In such procedures, the spreader module 400 canbe operated to draw anchoring points 125 a, 125 b closer together, forexample to close an open wedge 7 cut into the patient's bone 3. Moreparticularly, spreader module 400 can engage with anchoring points 125a, 125 b while in the opened configuration 400 b, with the anchoringpoints 125 a, 125 b being positioned on opposite sides of an open wedge7. The spreader module 400 can be subsequently operated towards theclosed configuration 400 a by turning hand wheel 409, thereby drawinganchoring points 125 a, 125 b together and closing the wedge 7.

Opening Validator

With reference now to FIGS. 5 and 5A, an opening validator 500 forvalidating the open wedge 7 formed in the patient's bone 3 is shownaccording to an embodiment. As can be appreciated, a desired openingangle of open wedge 7 can be predetermined according to a preoperativeplan. Although the gauge in spreader module 400 can provide anindication of the opening angle during the procedure, opening validator500 can provide a more precise confirmation as to whether the patient'sbone 3 has been opened the right amount to attain the desired angle ofopen wedge 7. Accordingly, opening validator 500 is provided to directlymeasure the open wedge 7 formed in the patient's bone 3.

In the present embodiment, opening validator 500 is a patient-specifictool designed to match the anatomy of the patient's bone 3. Morespecifically, the opening validator 500 is shaped and configured to fitsnugly in the opening 7 in the patient's bone 3 based on the expectedshape thereof as determined according to a pre-operative plan. Duringthe surgical procedure, as the patient's bone 3 is being spread to formopening 7, the opening validator 500 can be inserted into the opening 7.A snug fit of opening validator 500 can confirm that the correct opening7 has been formed, whereas an incorrect fit can indicate that anadjustment of opening 7 is necessary. It is appreciated that othermechanisms for validating the opening are also possible.

As shown in FIG. 5 , the opening validator 500 comprises a unitary body501, made from a rigid, biocompatible material. In the presentembodiment, the body 501 is made from a 3D printed plastic, although itis appreciated that other materials are possible, and that the validator500 can be made using other custom manufacturing processes. The body 501includes a handle end 503 and an operative end 505.

Handle end 503 is configured to facilitate manipulation of openingvalidator 500 during the surgical procedure. In the illustratedembodiment, handle end 503 comprises a handle 507 to allow the validator500 to be easily grasped and/or manipulated by hand. It is appreciated,however, that other interfaces for manipulating the validator 500 arealso possible. In the present embodiment, the handle 507 has asubstantially rectangular-shaped profile, including an anterior side 509a and a lateral side 509 b. The anterior 509 a and lateral 509 b aremarked to indicate proper orientation during the surgical procedure. Itis appreciated, however, that other shapes of handle 507 are alsopossible.

Operative end 505 is configured to engage with the opening 7 formed inthe patient's bone 3 at a predetermined position and orientation. Morespecifically, the operative end 505 comprises a wedge element 511 sizedand shaped to fit in the opening 7, and a tab element 515 to limit theinsertion depth of wedge 511. Wedge element 511 is shaped to conform tothe contour of interior surfaces 5 a, 5 b of the patient's bone 3 formedby planar cut 5 and confirm the height of opening 7 proximate theexterior surface of bone 3, and thus confirm opening angle 7 a. Morespecifically, wedge elements 511 comprises a top surface 513 a shaped toconform to the contour of top or proximal interior surface 5 a, and abottom surface 513 b shaped to conform to the contour of bottom ordistal interior surface 5 b. Similarly, tab element 515 is shaped toconform to the exterior contours of the patient's bone 3. Morespecifically, tab element 515 comprises a top surface 517 a shaped toconform to the exterior contour of the patient's bone 3 above the cut 5,and a bottom surface 517 b shaped to conform to the exterior contour ofthe patient's bone 3 below the cut 5. As show in FIG. 5A, when opening 7in the patient's bone 3 is opened to the right angle, and when validator500 is correctly positioned therein, top 513 a and bottom 513 b surfacesof wedge element 511, and top 517 a and bottom 517 b surfaces of tabelement 515 will simultaneously conform and engage with thecorresponding surfaces of the patient's bone 3, thereby locking openingvalidator 500 in place and confirming that configuration of opening 7matches the pre-operative plan. Any mismatch between the surfaces of thevalidator 500 elements and the surfaces of the patient's bone 3 canindicate that ad adjustment is required.

As can be appreciated, opening validator 500 can be used to assure thatopening 7 in patient's bone 3 is formed correctly prior to proceedingwith subsequent steps of the procedure. For example, it can confirmopening 7 prior to attaching a fixation plate, as will be describedbelow, to secure and retain opening. As another example, as illustratedin FIGS. 13A and 13B, the opening validator 500 can confirm opening 7prior to attaching predrilling module 300 a, and thus help position thesame, such that fastener holes can be drilled in the patient's bone 3after opening 7 has been formed.

Fixation Plate

With reference now to FIGS. 6A and 6B, a fixation plate 600 is shown.Fixation plate 600 comprises a body 601 made from a rigid, biocompatibleand degradation-resistant material, such as stainless steel or titanium,although it is appreciated that other materials are possible, includingdifferent metals and/or plastics and/or a combination thereof. In thepresent embodiment, fixation plate 600 is an osteotomy plate forsecuring to an antero-medial side of the patient's bone 3 and retainingthe opening 7 formed therein during an open-wedge osteotomy procedure.It is appreciated that in other embodiments, fixation plate 600 can beconfigured for securing to another side of the patient's bone 3depending on surgical requirements. In the present embodiment, body 601comprises a proximal section 601 a for securing to the patient's bone 3above opening 7, a distal section 601 b for securing to the patient'sbone 3 below opening 7, and an intermediate section 601 c for spanningthe opening 7. As will be described in more detail hereinafter, thepresent fixation plate 600 is patient-specific in that it has beendesigned based on the specific anatomy of the patient's bone 3 and basedon the specific needs of the patient determined during a preoperativeplan. The shape and configuration of fixation plate 600 can thereforevary from one procedure to another based upon the bone anatomy ofdifferent patients and based on their different needs.

The body 601 of fixation plate 600 is sized, shaped, and configured tofit snugly on the patient's bone 3 while also providing the requiredsupport and being minimally noticeable under the patient's skin. In thepresent embodiment, body 601 is thin and substantially flat, and isconfigured to follow the contours of the patient's bone 3. In thisconfiguration, for example, when the fixation plate 600 is secured tothe patient's bone 3, it can protrude from the surface of the patient'sbone 3 at a uniform height along the entire body 601. Moreover, in someembodiments, body 601 can be designed to have a thickness which variesin different locations, allowing body 601 to have increased or reducedstrength or rigidity where required and/or allow body 601 to protrudeless noticeably from the patient's bone at certain areas.

The body 601 of fixation plate 600 comprises a bone interface side 603and an outward-facing side 605. Bone interface side 603 comprises aninner surface for positioning adjacent the patient's bone 3. Thecontours of inner surface of bone interface side 603 are complementaryin shape to surface contours of a predetermined position on thepatient's bone 3. In this fashion, fixation plate 600 can fit snugly ona position of the patient's bone 3 determined preoperatively.Outward-facing side 605 is substantially smooth and/or flat to make itminimally noticeable under the patient's skin. In the presentembodiment, the outward-facing side 605 comprises sloped and/orchamfered edges 607 which provide a smoother transition between the body601 of fixation plate 600 and the patient's bone 3.

The fixation plate 600 is secured to the patient's bone 3 via fasteners609. In the present embodiment, fasteners 609 comprise surgical screwswhich are drilled into the patient's bone 3, although it is appreciatedthat other type of fasteners are possible. The fasteners 609 engage withplate 600 via apertures or canals 610 opening on the bone interface side603 and the outward facing side 605 of the plate 600. As can beappreciated, canals 610 can be sized and shaped to receive differentsizes of fasteners 609. Moreover, canals 610 can be configured to guidefastener 609 at a predetermined angle or orientation as it is insertedinto the patient's bone 3. For example, in the present embodiment,canals 610 comprise sidewalls extending through the thickness of thebody 601 of plate 600 at a predetermined angle to guide the fasteners609 as they are drilled through the canals 610. In some embodiments, thesidewalls of canals 610 can be threaded, for example to engage withcorresponding threads of fasteners 609 as the fasteners 609 are beingdrill through canals 610, and/or to engage or lock with a head of thefasteners 609 once fully inserted. The sidewalls of canals 610 canfurther be configured to abut against a head of fastener 609 to blockthe fastener 609 from being inserted too deep into the patient's bone 3.

As can be appreciated, based on a preoperative plan, fixation plate 600can be designed with a different number and configuration of canals 610for receiving a different number and configuration of fasteners 609based on the specific needs of the patient to promote optimal securingof the plate 600. Moreover, the fixation plate 600 can be configuredsuch that it can accommodate combinations of different sizes offasteners 609 (both diameter and length) and different orientation offasteners 609, for example based on the position of the patient's bone 3to which a particular fastener 609 is to be secured. In the illustratedembodiment, the plate 600 is configured to accommodate two largelaterally-spaced fasteners 609 in the proximal section of body 601 a,and two smaller vertically-spaced fasteners 609 in the distal section ofbody 601 b. As will be explained in more detail hereinafter, many otherconfigurations of plate 600 are possible.

In some embodiments, additional support members can be provided tofurther assist fixation plate 600 in retaining the opening 7 formed inthe patient's bone 3 and/or to assist in correctly positioning fixationplate 600 relative to opening 7. By way of example, and with referenceto the embodiment of FIGS. 14, 14A, 14B, and 14C, a wedge element 611can be provided to abut against internal surfaces 5 a, 5 b on oppositesides of opening 7 when fixation plate 600 is positioned on thepatient's bone 3. As can be appreciated, as a load is applied acrossopening 7, the wedge element 611 can exert an opposing force on thepatient's bone 3 via internal surfaces 5 a, 5 b. In this configuration,a load across the opening 7 can be borne by the wedge element 611 anddissipated through the patient's bone 3, rather than being borne by thefasteners 609 holding the plate 600 in place. In the illustratedembodiment, wedge element 611 is formed as an integral part of body 601of fixation plate 600, and is made from the same rigid, biocompatiblematerial, i.e. stainless steel or titanium. It is appreciated, however,that in other embodiments, wedge element 611 can be a separate piecewhich can be fastened or secured to the fixation plate 600 and/ordirectly to the patient's bone 3. It is further appreciated that wedgeelement 611 can be made of a different material, such as a rigid plasticor the like, depending on the required structural properties.

In the present embodiment, wedge element 611 extends from the boneinterface side 603 of fixation plate 600, and is positioned onintermediate section 601 c of fixation plate body 601. In thisconfiguration, wedge element 611 extends inside opening 7 when thefixation plate 600 is secured to the patient's bone 3. The wedge element611 comprises a proximal abutment 613 for abutting against a proximalinternal surface 5 a of bone 3, and a distal abutment 615 for abuttingagainst a distal internal surface 5 b of bone 3. Proximal 613 and distal615 abutments are spaced apart from one another via a concave canal 617.In this configuration, a certain amount of flexure is permitted in therigid body 601 of fixation plate 600 as a load is applied acrossabutments 613, 615. It is appreciated, however, that in otherembodiments, wedge element 611 can be a solid block having abutments613, 615 defined on opposite sides thereof.

As with the other components of fixation plate 600, the wedge element611 can be configured according to patient-specific needs. For example,based on a preoperative plan and 3D models of the patient's bone 3,various components, surfaces, contours, etc. of the wedge element 611and be shaped and configured to conform to the specific anatomy of thepatient's bone 3 and/or opening 7 formed therein. Wedge element 611 canfurther be configured to provide varying levels of structural support asrequired based on patient-specific needs.

More specifically, and with reference to FIGS. 16 and 16A, an exemplaryembodiment of a wedge element 611 is shown. In the illustratedembodiment, the body 601 of fixation plate 600 has a nominal thickness602 in intermediate section 601 c, and wedge element 611 extendstherefrom. The wedge element 611 comprises proximal 613 and distal 615abutments extending from body 601 and extends along a width 612 abetween anterior 619 and posterior 621 sides. The proximal 613 anddistal 615 abutments have respective bone contacting bearing surfaces613 a and 615 a spaced apart from one another by a spanning distance 612b, for respectively abutting against proximal 5 a and distal 5 binternal surfaces on opposite sides of opening 7 in the patient's bone3. As can be appreciated, the spanning distance 612 b can be adjustedaccording to the expected size of opening 7 as determined in apreoperative plan, to extend precisely between proximal 5 a and distal 5b internal surfaces and abut against the same. By precisely spanning thedistance between proximal 5 a and distal 5 b internal surfaces, wedgeelement 611 can provide the necessary support to retain the internalsurfaces 5 a, 5 b a fixed distance from one another, and retain opening7 at the desired opening angle. In this configuration, wedge element 611can further assist in correctly positioning fixation plate 600 on thepatient's bone 3. As can be appreciated, the wedge 611 will only be ableto fit inside the opening 7 at a position where the opening is wideenough to accommodate the spanning distance 612 b of abutments 613, 615.Accordingly, the wedge element 611 can be designed with a spanningdistance 612 b such that it fits inside opening 7 at a predeterminedposition and orientation relative to the patient's bone 3, as determinedin a preoperative plan, thereby positioning the fixation plate 600 towhich the wedge element 611 is secured.

In the present embodiment, and as shown in FIG. 24A, wedge 611 isconfigured to abut against the patient's cortical bone 3 a, i.e. thehard outer layer of patient's bone 3, as opposed to the soft trabecularbone 3 b. Accordingly, and referring back to FIGS. 16 and 16A, proximal613 and distal 615 abutments can be sized and shaped to interface withthe patient's cortical bone 3 a while avoiding contact with thepatient's trabecular bone 3 b. More particularly, in the presentembodiment, bone contacting surfaces 613 a and 615 a are substantiallyplanar and extend substantially perpendicular relative to body 601through respective depths 614 a and 616 a. As can be appreciated, depths614 a and 616 a can be adjusted based on the thickness of the patient'scortical bone 3 a, such that the abutments 613 and 615 extend intoopening 7 to a depth corresponding to the thickness of the cortical bone3 a, for example to approximately 4 mm. In the present embodiment, bonecontacting surfaces 613 a and 615 a have the same depths 614 a, 616 a,but it is appreciated that in other embodiments, the depths can bedifferent, for example depending on the expected position andorientation of wedge 611, and/or variances in the thickness of thepatient's cortical bone 3 a. As can be appreciated, the surface areas ofbearing surfaces 613 a and 615 a are defined by depths 614 a, 616 a, andwidth 612 a of wedge 611. Accordingly, width 612 a can be adjusted, inaddition to depths 614 a, 616 a, according to the required surface areaof bearing surfaces 613 a, 615 a. In the present embodiments, width 612a is approximately 8 mm, but other sizes are also possible depending onpatient-specific requirements.

As mentioned above, the wedge element 611 can be configured to providedifferent levels of support based on patient-specific needs. Forexample, for some patients, it may be desirable to have more rigidity inthe fixation plate 600, whereas for other patients, it may be desirableto allow a certain amount of micromovements via flexure or deformationof the fixation plate 600 across the opening 7. Accordingly, respectivethicknesses 614 b and 616 b of proximal 613 and distal 615 abutments canbe adjusted based on a desired level of rigidity. For example, in someembodiments, such as the one illustrated in FIGS. 16 and 16A, abutments613, 615 can be relatively thin members extending from body (for examplewith thicknesses 614 b and 616 b of approximately 1 mm), thus allowing acertain amount of deformation as loads are applied to their respectivebearing surfaces 613 a, 615 b. In other embodiments, abutments 613, 615can be relatively thick and/or can have a thickness corresponding to thespanning distance 612 b of wedge 611 (i.e. the wedge being formed from asolid block of material, with abutments 613, 615 defined on oppositesides thereof), thereby providing increased rigidity and allowing littleto no deformation of wedge 611 under typical loads. In the embodimentillustrated in FIGS. 16 and 16A, the respective thicknesses 614 b, 616 bof abutments 613 and 615 are the same, however it is appreciated that inother embodiments they can be different, for example to providedifferent levels of rigidity in proximal and distal sections of plate600 and/or to control the distribution of forces in wedge 611 as a loadis applied to abutments 613, 615.

As can be appreciated, abutments 613 and 615 can be designed withdifferent shapes and configurations which can further affect therigidity and/or the distribution of forces in wedge 611. For example, inthe embodiment shown in FIGS. 16 and 16A, abutments 613 and 615 areconfigured as curved members with a progressive reduction of theirdepths 614 a, 616 a towards a central area of wedge 611. In other words,a canal 617 extends along a height 617 a between respective interioredges 613 b, 615 b of abutments 613 and 615. The canal 617 has a depth617 b which increases towards the central area of wedge 611, therebysubtracting from the depths of abutments 613, 615. In the presentembodiment, the depth 617 a of canal 617 follows a polynomial curve(i.e. AX²+BX+C), reaching a maximum depth 617 b midway along its height617 a. Thus, when viewed from posterior 219 or anterior 221 sides, thecanal 617 has a parabolic or C-shaped profile. In this configuration,when a load is applied across abutments 613, 615, stresses can befocused towards the central area of the wedge 611. Although in thepresent embodiment the canal 617 is substantially C-shaped, it isappreciated that other configurations are also possible, includingdifferent shapes having progressive and/or abrupt changes in depth 617b. For example, in some embodiments, the canal 617 can have asubstantially V-shaped profile, a substantially rectangular-shapedprofile, etc. In the present embodiment the maximum depth 617 a of canal617 corresponds to the depths 614 a, 616 a of abutments 613, 615. Inthis configuration, the canal 617 does not extend past the thickness 602of plate 600. It is appreciated, however, that other configurations arepossible. For example, the canal 617 can be shallower than depths 614 a,616 a, such that a minimum or base thickness 618 of plate 600 betweenabutments 613, 615 is thicker than a nominal thickness 602 of plate 600adjacent to the wedge 611.

In the illustrated embodiment, the wedge 611 can be referred to as astraight wedge in that the bearing surfaces 613 a, 615 a aresubstantially straight and uniform. For example, bearing surfaces 613 a,615 a are substantially rectangular, and are substantially parallel toone another. Similarly, the canal 617 is straight and uniform along thewidth 612 a of wedge 611. It is appreciated, however, that the shape andorientation of bearing surfaces 613 a, 615 a, and/or canal 617 can beadjusted to better conform to the specific needs of a patient. Forexample, as illustrated in FIGS. 20, 20A and 20B the surface area ofbearing surfaces 613 a, 615 a of a straight wedge 611 may not be in fullcontact with interior surfaces 5 a, 5 b of opening 7, and can thuscreate areas of increased pressure. However, if wedge 611 is configuredto follow the shape of interior surfaces 5 a, 5 b as shown in FIGS. 21,21A and 21B, a superior interface between wedge 611 and the patient'sbone 3 can be achieved (i.e. increased surface area of contact),allowing for better stress distribution through the bone.

With reference now to FIGS. 15, 15A and 15B, a wedge element 611 isshown according to an alternate embodiment in which abutments 613, 615are shaped to follow the specific shape and contours of opening 7. Morespecifically, in the illustrated embodiment, bearing surfaces 613 a, 615a are sloped or tapered along the direction of width 612 a. Similarly,bearing surfaces 613 a, 615 b are sloped or tapered along the directionof their depths 614 a, 616 a. In this configuration, when the wedge 611is positioned inside opening 7, bearing surfaces 613 a, 615 a can followthe slope of interior surfaces 5 a, 5 b, and increase the contactsurface area therewith. This configuration of wedge 611 can furtherallow for the correction of varus/valgus deformity in the frontal planeas well as the correction of the tibial slope in the sagittal plane. Inthe present embodiment, bearing surfaces 613 a, 615 b are taperedinwards along width 612 a towards the posterior side 621, to follow acorresponding narrowing of opening 7 towards a posterior side of thepatient's bone 3. It is appreciated, however, that the taperingdirection and magnitude can differ according to the expected shape ofthe opening 7 as determined in a preoperative plan. It is alsoappreciated that the proximal 613 a and distal 615 a bearing surfacescan be tapered at different angles. In the present embodiment, bearingsurfaces 613 a, 615 a are also tapered inward along the direction oftheir depths 614 a, 616 a. In this configuration, the bearing surfaces613 a, 615 a can follow the slope of interior surfaces 5 a, 5 b as theyconverge towards hinge 9 at opening angle 7 a, as shown in FIGS. 22 and22A. Again, it is appreciated that the tapering angle of bearingsurfaces 613 a, 615 a can be different.

In the present embodiment, the width 612 a of the wedge 611 is uniformalong the wedge span 612 b. In other words, bearing surfaces 613 a, 615a are aligned with one another, and have the same width 612 a. It isappreciated, however, that in other embodiments, bearing surfaces 613 a,615 a can have different widths and/or can be offset from one another.For example, as illustrated in FIGS. 23 and 23A, load distribution inthe patient's bone 3 can be physiologically more important in the medialcompartment. Accordingly, when plate is secured to patient's bone 3across opening 7, the plate 600 can undergo a rotation effort in theantero-medial plane. To equilibrate the stress induced in the wedge 611and bone 3, bearing surfaces 613 a, 615 a can have different widthsand/or can be offset, for example by being configured with tapered sideedges 613 c, 615 c. It is appreciated that other relative size andpositions of bearing surfaces 613 a, 615 a are also possible indifferent embodiments, according to patent specific requirements.

In the embodiment illustrated in FIGS. 15, 15A and 15B, the wedgeelement 611 is further configured with bearing surfaces 613 a, 615 awhich conform to a shape of the patient's cortical bone 3 a to ensurebetter contact therewith, and avoid contact with the trabecular bone 3b. As can be appreciated, the thickness of the patient's cortical bone 3a can vary at different points along the circumference of the patient'sbone 3. Accordingly, the respective depths 614 a, 616 a of abutments613, 615 can in direction of wedge width 612 a. In the presentembodiment, and as best illustrated in FIG. 15B, depths 614 a ofproximal abutment 613 decreases from anterior side 619 to posterior side621, thus defining a bearing surface 613 a having a sloped or taperedinterior edge shaped to match a thinning of the patient's cortical bone3 a towards posterior side 621. Although in the present embodiment theinterior edge of bearing surface 613 a has a sloped, linear shape, it isappreciated that other shapes are also possible depending on thespecific shape of the patient's cortical bone 3 a. Moreover, althoughonly the proximal abutment 613 is shown in FIG. 15B, it is appreciatedthat distal bearing surface 615 a can be configured with a similar ordifferent shape.

In the present embodiment, the wedge element 611 is further configuredwith an evolutive canal 617, i.e. a canal having a shape which changesor evolves along width 612 a of wedge 611. As shown in FIGS. 15, 15A and15B, the height 617 a of canal 617 varies along width 612 a wedge. Morespecifically, interior edges 613 b, 615 b of abutments 613, 615 aretapered inwards from posterior side 621 to anterior side 619, resultingin the canal height 617 a decreasing from posterior side 621 to anteriorside 619. In the present embodiment, edges 613 b, 615 b are angledinward towards one another at substantially equal and opposite angles,although it is appreciated that in other embodiments, angles of edges613 b, 615 b can differ, or edges 613 b, 615 b can be angled andparallel to one another. It is further appreciated that in otherembodiments, edges 613 b, 615 b can follow curved paths. As can beappreciated, the present configuration of canal 617 can also allowabutments 613, 615 to have evolutive thicknesses 614 b, 616 b alongwidth 612 a. More particularly, in the present embodiment, respectivethicknesses 614 b, 616 b of abutments 613, 615 increase from posteriorside 621 to anterior side 619.

In the present embodiment, the wedge element 611 is further configuredwith a minimum or base thickness 618 of plate 600 which varies alongwidth 612 a of wedge 611. As best shown in FIG. 15B, the base thickness618 increases from posterior side 621 to anterior side 619. For example,on posterior side 621, the base thickness 618 can correspond to thenominal thickness 602 of plate 600, whereas on anterior side 619, thebase thickness 618 can be greater than the nominal thickness 602.Although in the present embodiment the base thickness 618 increaseslinearly along width 612 a, it is appreciated that in other embodiments,the change in thickness 618 can be nonlinear. As can be appreciated,variances in base thickness, along with the variances in the canalconfiguration and/or abutment thicknesses can allow for the rigidityand/or permitted amount of micromovements between abutments 613, 615 tovary across the width 612 a of wedge 611.

In the embodiments described above, plate 600 is provided with a singlewedge 611 was shown for engaging in opening 7 along an antero-medialside of the patient's bone 3. It is appreciated, however, that in otherembodiments, other wedge configurations are possible. For example, withreference to FIGS. 17, 17A, 17B, 18A and 18B, a double wedge plate 600is shown according to an embodiment. In the illustrated embodiment,plate 600 is provided with a first anterior wedge 611 a, and a secondposterior wedge 611 b spaced apart from one another in intermediatesection 601 of plate body 601. In the present configuration, wedges 611a and 611 b are spaced apart from one another via an opening 623 inplate body 601. As can be appreciated, opening 623 can help reduce theweight of plate and/or to encourage flexure in the intermediate section601 c. It is appreciated that in other embodiments, opening 623 need notbe provided, and plate body 601 can be closed between wedges 611 a and611 b.

When plate 600 is engaged with patient's bone 3, wedges 611 a and 611 bengage in opening 7 on an antero-medial side of the patient's bone 3,providing support at anterior and posterior positions. As with theembodiments of the patient-specific wedges described above, each ofwedges 611 a and 611 b can be configured according to patient-specificneeds, and based on patient-specific anatomy. For example, asillustrated in FIG. 24B, each of wedges 611 a and 611 b can be shapedand configured to follow and abut the patient's cortical bone 3 a. Theother size and shape parameters of wedges 611 a and 611 b, as describedabove, can also be customized based on the expected position of wedge611 a, 611 b as determined preoperatively, and the dimensions of wedges611 a, 611 b can differ from one another. For example, in the presentembodiment, posterior wedge 611 b has a spanning distance greater thanthe spanning distance of anterior wedge 611 a to account for a wideningof opening 7 towards the posterior. The size, shape and configuration ofwedges 611 a, 611 b can further be configured such that wedges 611 a and611 b work together to provide the necessary level of support, and/oraccount for stress distribution in the plate 600 and/or the patient'sbone 3 based on patient-specific requirements as determinedpreoperatively.

In the embodiments described above, the wedge 611 is configured toengage in, and provide support to, opening 7 on an antero-medial side ofthe patient's bone 3. It is appreciated, however, that in someembodiments, further support may be desired towards the anterior and/orposterior of the patient's bone 3. Accordingly, in some embodiments, thewedge 611 can be configured as an extended wedge with a section whichextends away from the plate body 601 in the anterior and/or posteriordirection. With reference to FIG. 19 , an exemplary fixation plate 600with an extended wedge 611 is provided. In the illustrated embodiment,the wedge 611 is a double wedge and comprises an anterior wedge element611 a and a posterior wedge element 611 b. The posterior wedge element611 b is configured as an extended wedge which comprises an anteriorsection 625 extending from plate body 601 along the antero-medialsection of the patient's bone 3, and a posterior section 627 whichextends from anterior section 625 towards the posterior of the patient'sbone 3. As can be appreciated, and as shown in FIG. 24C, the extendedwedge element 611 b is configured to follow the contour of the patient'sbone 3 as it wraps around towards the posterior, and therefore defines aC-shape. It is appreciated, however, that other shapes are possible. Itis further appreciated that in other embodiments, the extended wedge cancomprise an anterior-extending section which can wrap around an anteriorsurface of the bone. It should be appreciated that although theposterior wedge 611 b is configured as an extended wedge in the presentembodiment, in other embodiments the anterior wedge 611 a can beconfigured as an extended wedge in place of, or in addition to theposterior wedge 611 b. Finally, it should be appreciated that anextended wedge can be provided as part of a plate having a single wedge.

As can be appreciated, as with the other embodiments of wedges describesabove, the extended wedge 611 can have contours and surfaces thatconform to the specific shape of the patient's bone 3. For example, asshown in FIG. 24C, the extended wedge 611 b can be sized and shaped tofollow and abut against the patient's cortical bone 3 a, while avoidingthe trabecular bone 3 b. The extended wedge 611 b can further beconfigured with tapered and/or offset abutments surfaces as describedabove and can be provided with a straight or evolutive channel toprovide flexure if desired.

Spacing Element

In the embodiment illustrated in FIG. 6B, the fixation plate 600 is indirect contact with the patient's bone 3. In other words, the innersurface of bone interface side 603 of fixation plate 600 abuts directlyagainst the surface of the patient's bone 3. It is appreciated, however,that in other embodiments, the fixation plate (or section thereof) canbe spaced apart from the patient's bone 3 and not be in direct contacttherewith. Accordingly, bone interface side 603 can be configured toconform to surface contours of the patient's bone 3 at a predeterminedspacing therefrom, and spacing elements can be provided to create aspacing between inner surface of bone interface side 603 and the surfaceof the patient's bone 3 when the fixation plate 600 is secured to thepatient's bone 3.

With reference to FIG. 7 , a spacing element 700 for spacing a fixationplate from a patient's bone is shown according to an embodiment. Spacingelement 700 comprises a body 701 made from a rigid, biocompatiblematerial, such as metal, which can be the same or different materialthan fixation plate. Body 701 has a bone interface side 703 forcontacting the patient's bone, and a plate interface side 705 forcontacting the fixation plate. Sidewalls 707 extend between the boneinterface side 703 and the plate interface side 705, defining athickness 709 of the spacing element. The body 701 further defines acentral aperture 710 for allowing a corresponding fastener to passthere-through. The central aperture extends through the thickness 709 ofthe body 701, and opens on the bone interface side 703 and the plateinterface side 705. In the present embodiment, the body 701 issubstantially cylindrical in shape, with a radius 711. It isappreciated, however, that other shapes are also possible. For example,in some embodiments, body 701 can be frustoconical in shape, and canhave a radius 711 which varies along thickness 709.

In the present embodiment, the spacing element 700 is custom made toconform to the specific anatomy of a patient's bone. More specifically,the bone interface side 703 comprises a surface having contoursconforming to the surface contours of the patient's bone. As can beappreciated, the position of spacing element 700 can be determinedduring pre-operative planning using a 3D model of the patient's bone,and the surface of bone interface side 703 can be configured to conformto the patient's bone at the determined position, such that the spacingelement 700 fits snugly against the patient's bone at a specificposition and orientation. The thickness 709 and radius 711 of spacingelement 700 can further be adjusted based on patient-specificrequirements. For example, as will be discussed in more detail below,thickness 709 can be adjusted to create a larger or smaller spacingdistance, and radius 711 can be adjusted to increase or decrease thesurface area of spacing element 700 in contact with the patient's boneand/or the fixation plate. In the present embodiment, the surface ofplate interface side 705 is substantially flat and planar, however it isappreciated that in other embodiments, it can be configured to conformto a particular contour of the plate. Moreover, in some embodiments,plate interface side 705 and/or sidewalls 707 can be shaped andconfigured to key into fixation plate, for example to assure properalignment and relative orientation of spacing element 700 and fixationplate. In some embodiments, interface side 705 can be configured toremovably adhere or secure to fixation plate.

With reference to FIG. 8 , spacing element 700 is positioned between thefixation plate 600 and the patient's bone 3 to create a spacing 633there-between. In the present embodiment, a plurality of spacingelements 700 is provided. Each of the spacing elements 700 is alignedwith a corresponding fastener 609 and is specifically configured toconform to a particular position on the patient's bone 3. Each fastener609 extends through the fixation plate 600 and through a correspondingspacing element 700 before securing in the bone 3. In the presentembodiment, a spacing element 700 is provided for each fastener 609,although it is appreciated that in other embodiments, spacing elements700 can be provided for only some of the fasteners 609. In the presentembodiment, the spacing elements 700 are positioned relative to thefixation plate 600 during the surgical procedure, although it isappreciated that in other embodiments, spacing elements 700 can bepre-adhered to fixation plate 600.

As can be appreciated, the number and configuration of the spacingelements 700 can be selected based on patient-specific spacingrequirements. For example, in the present embodiment, spacing elements700 are configured to provide a spacing 633 of approximately 2 mm.However, as illustrated in FIGS. 8A, 8B and 8C, other embodiments ofspacing elements 700 a, 700 b, 700 c can have different thicknesses 709to provide different spacing distances 633 a, 633 b, 633 c, for examplewithin the range of approximately 1.8 mm to 2.2 mm. In the embodimentillustrated in FIG. 8 , the spacing elements 700 are configured toprovide a consistent or uniform spacing along the entire area offixation plate 600. However, it is appreciated that in otherembodiments, plate 600 and spacing elements 700 can be configured suchthat some sections of spacing plate 600 are spaced further apart fromthe patient's bone 3 than other sections. For example, proximal section601 a can be spaced away from bone 3 at a first spacing distance 633 a,whereas distal section 601 b can be spaced away from bone 3 at a secondspacing distance 633 b. Accordingly, a single plate 600 can be securedto bone 3 using a plurality of spacing elements 700 having differentthicknesses. Moreover, in some embodiments, the spacing elements 700used for the same plate 600 can have different radii 711, such that somespacing elements 700 have larger bone-contacting surfaces than others.

In the above-described embodiments, spacing elements 700 are independentfrom plate 600 in that they are not integrally formed as part of platebody 601. Instead, the described spacing elements 700 can be removableand/or repositionable relative to plate 600 and/or can be made fromdifferent materials than plate 600. It is appreciated, however, that inother embodiments, spacing elements 700 can be integrally formed as partof plate 600. Accordingly, a plate with integrally formed spacingelements 700 can be referred to a low contact plate, in that the plateis configured to have a bone interface side with reduced contact surfacearea with the patient's bone 3 by way of spacing elements 700. Incontrast, a plate without spacing elements can be referred to as a fullcontact plate, in that the bone interface side will be in full contactwith the patient's bone 3.

With reference to FIGS. 25A, 25B, 25C, 25D and 25E, an exemplary fullcontact plate 600 is shown according to an embodiment. In theillustrated embodiment, the plate 600 comprises a body 601 with a boneinterface side 603 opposite an outward facing side 605. Fasteneraperture 610 extend through body 601 and open on the bone interface 603and outward facing 605 sides. As can be appreciated, the bone interfaceside 603 is substantially flat and featureless (i.e. without bumps,protrusions, etc.), defining a continuous or unbroken bone contactingsurface 604 extending substantially throughout the entirety of the boneinterface side 603. Although in the present embodiment the boneinterface side 603 is substantially planar, it is appreciated that thisis for illustrative purposes only, and that in other embodiments thebone interface side 603 can follow the contours of the surface of apatient's bone 3 while having a flat and featureless surface to allowfull and direct contact with the surface of the patient's bone 3.

In the present embodiment, outward facing side 605 is provided withsurface features to allow for a smooth transition between the surface ofthe patient's bone 3 and the plate 600. A sloped or chamfered edge 607extends around the perimeter of body 601 on outward facing side 605,providing a gradual transition between the bone interface side 603 and ahighest point on the outward facing side 605. The plate 600 is furtherconfigured with annular recesses 608 a and/or annular bumps orprotrusions 608 b around fastener apertures 610 on outward facing side605. The recesses 608 a and/or bumps 608 b can allow for a fastener tobe seated in plate 600 when engaged in aperture 610 and prevent thefastener from protruding from a highest point of outward facing side605. As can be appreciated, this configuration can allow for a smoothtransition between fastener head and plate 600.

An exemplary low contact plate 600 is shown according to an embodimentin FIGS. 26A, 26B, 26C, 26D, 26E and 26F. As can be appreciated thestructure of low contact plate 600 is substantially similar to the fullcontact plate described above, including similar surface features onoutward facing side 605. However, as best seen in FIGS. 26B, 26D, 26Eand 26F, bone interface side 603 is provided with surface features inthe form of annular bumps or protrusions around apertures 610, definingspacing elements 700. In the present embodiment, spacing elements 700are integrally formed as part of plate body 601 and are formed from thesame material. It is appreciated, however, that in other embodiments,spacing elements 700 can be fused to body 601 and/or can be made of adifferent material. As can be appreciated, spacing elements 700 define aplurality of bone contacting surfaces 604 on bone interface side 603.This can reduce the overall area of plate body 601 in contact with thepatient's bone 3, as the plate will only contact the bone along thesurface 604 of spacing elements 700, rather than along the entirety ofthe bone interface side 603. It should be appreciated that in thepresent embodiment, bone contacting surfaces 604 on spacing elements 700are substantially planar for illustrative purposes only. In otherembodiments, the bone contacting surfaces 604 on spacing elements 700can be shaped to conform to the surface contours of the patient's bone 3to assure full contact between surface 604 and the surface of thepatient's bone 3. Finally, although in the present embodiment spacingelements 700 are provided as annular surface features around apertures610, it should be appreciated that in other embodiments, the surfacefeatures defining spacing elements 700 can be provided elsewhere on boneinterface side 603 of plate 600.

Fasteners

As discussed above, fixation plate 600 can be secured to a patient'sbone 3 via fasteners 609. The fixation plate 600 can be configured withdifferent numbers of apertures 610 to accommodate different numbers offasteners 609, and apertures 610 can be sized to accommodate differentsizes of fasteners 609 and oriented to guide fasteners 609 atpredetermined angles into the patient's bone 3. Accordingly, the surgeoncan select the desired number, size, position, and orientation offasteners 609 during a preoperative plan, and fixation plate 600 can beconfigured to accommodate the same. The surgeon can further select adesired length of fastener, for example depending on the desired depththat fastener should extend into the patient's bone 3.

As can be appreciated, different types of fasteners 609 can be providedto secure fixation plate 600 to the patient's bone 3. With reference toFIGS. 27 and 27A, an exemplary embodiment of a fastener 609 in the formof a flat-headed surgical screw is provided. The fastener 609 comprisesa body 629 with a head 629 a and a threaded section 629 b. The fastener609 is a flat-headed fastener in that head 629 a has a substantiallyplanar surface, although it is appreciated that in other embodiments,other shapes are possible.

As illustrated in FIGS. 28 and 28A, the illustrated fastener 609 issized and shaped to cooperate with aperture 610 in plate 600. Morespecifically, fastener 609 is sized to engage in a fastener seat 608defined via annular recess 608 a and annular bump 608 b around aperture610. In this configuration, when fastener 609 is engaged in aperture610, head 629 a is flush with annular bump 608 b, defining a smoothcontour therewith, and preventing fastener 609 from protruding fromplate 600.

In the present embodiment, fastener 609 is configured to allowsupplementary angulation while it is inserted during a surgicalprocedure. As can be appreciated, sidewalls of aperture 610 and/orfastener seat 608 can be angulated such that fastener 609 will beoriented at a predetermined angle when it is inserted into aperture 610,as defined according to the preoperative plan. However, with furtherreference to FIG. 29 , in the present embodiment, the fastener head 629a is provided with an undersurface 631 configured to cooperate withfastener seat 608 to allow supplemental fastener angulation (I). Morespecifically, in the present embodiment, undersurface 631 and/or annularrecess 608 a are curved, thereby allowing head 629 a to pivot slightlyin seat 608, thereby allowing a supplemental angulation it, of fastener609. In this configuration, when the fastener 609 is inserted, it willpenetrate the patient's bone 3 generally at an angle as determinedpreoperatively. However, a surgeon will have the freedom of adjustingthe angle of fastener slightly by supplemental angulation (I), forexample by up to 3 degrees. In some embodiments, a locking element canbe provided to lock the angle of fastener 609 after is has been insertedand avoid subsequent movement thereof. For example, a cap element can bescrewed over and/or engage with head 629 a to prevent subsequentangulation of fastener 609.

Although a particular type of fastener 609 was described herein, it isappreciated that other types of fasteners are also possible. Forexample, in some embodiments, the fastener 609 can be self locking. Insuch configurations, the fastener head 629 a can be provided withthreads for engaging with corresponding threads seat 608 of plate 600,thereby locking fastener head 629 a in seat at a predeterminedorientation and preventing supplementary angulation thereof.

Preoperative Planning and Surgical Toolkit

As can be appreciated, the tools and guides described above can beprovided as part of a surgical toolkit comprising generic andpatient-specific components. In other word, the toolkit includescomponents designed specifically for a patient, and which can only beused to carry out a specific planned surgery (i.e. single usecomponents), and non-specific components which can be re-used duringsubsequent surgical procedures (i.e. multi-use components). Thepatient-specific components can be designed and fabricated to assist inperforming steps of a high-tibial osteotomy procedure as determinedaccording to a preoperative plan.

With reference to FIG. 30 , a preoperative planning method 800 is shownaccording to an embodiment. The method 800 comprises a first step 801 ofconstructing a 3D model of a patient's bones. The 3D model can beconstructed, for example, by using different types of medical imagingtechniques, such as a CT scan, to acquire images of the patient's bones,and assembling said images to form a 3D model which describes thestructure of the patient's bones, including their shapes, surfaces,and/or volumes, among other parameters. The 3D model can subsequently beused to preoperatively simulate the effect of surgical interventions onthe patient's bones.

A second step 803 of the method can comprise selecting a desiredcorrection angle to apply to the patient's tibia bone via surgicalintervention. In an embodiment, a computer program can calculate themechanical axis of the patient's knee and/or the distribution ofstresses within the patient's knee, using the 3D model. The computerprogram can allow modifying the 3D model to adjust the orientation ofthe patient's tibia bone relative to the patient's femur. The mechanicalaxis and/or distribution of stresses in the knee can be recalculatedfollowing the adjustment, and a correction angle can be selected once adesired knee alignment has been attained.

As can be appreciated, in some embodiments, the correction angle can beselected automatically by the computer program. In such embodiments, thecomputer program can determine an optimal correction angle which wouldresult in a mechanical axis which evenly distributes stresses throughoutthe patient's knee, or which reduces stresses on a worn part of thepatient's knee. In other embodiments, the optimal correction angle canbe selected by a user. For example, the 3D model, mechanical axis and/orstress distributions can be presented on a display of a computingdevice, and the user can be provided with controls to adjust thecorrection angle. As the user adjusts the correction angle, themechanical axis and the distributions of stresses can be recalculated inreal time and shown on the display to help the user visualize the effectof changing the correction angle. The user can then select a desiredcorrection angle once the mechanical axis and/or stress distributionsare as desired. In some embodiments, a computer can automaticallyrecommend an optimal correction angle based on predetermined parameters,and the user can adjust the 3D model as necessary to select a finaldesired correction angle.

Once the correction angle has been selected, a third step 805 cancomprise designing a patient-specific fixation plate to retain thepatient's tibia bone at the selected correction angle. As can beappreciated, the 3D model can be used to determine the expected shapeand form of the patient's bone caused by surgical intervention. Morespecifically, the steps of the surgical procedure can be simulated usingthe 3D model, allowing the 3D model to describe the expected shape andform of the patient's bone during and after the surgical procedure. Forexample, the 3D model of the patient's tibia bone can be virtually cutand opened or closed to attain the selected correction angle. Apatient-specific fixation plate can then be designed to conform to thefinal expected shape and contours of the patient's bone and the open orclosed wedge formed therein, based on the shape and form described bythe 3D model.

In an embodiment, the fixation plate can be designed from scratch andcompletely custom made for the patient. Rather than starting from amodel or template and modifying the same to conform to the patient (ex:providing a model of a standard T-shaped plate, and modifying thecontours of the standard plate to match the contours of the patient'sbones), the fixation plate can be designed from scratch based onpatient-specific needs, such as a desired number, position,configuration, of fasteners, among others. Accordingly, the fixationplate can be designed with non-standard, complex and/or freeform shapesto conform to patient-specific needs.

For example, in some embodiments, the computer program can provide auser interface which allows the user to design and visualize thefixation plate on the 3D model of the patient's bone. The interface caninclude controls which allow the user to position fasteners on thepatient's bone and customize parameters of each fastener. For example,the user can select a desired fastener from a library including aplurality of fasteners of different types, shapes, lengths, diameters,etc., and select a desired position and orientation of said fastener.The user can continue to position any number of fasteners on the bone asdesired. When the fasteners are positioned, the computer program candesign a fixation plate which accommodates all the fasteners positionedby the user. For example, the computer program can determine an optimalshape which joins all the fasteners, while providing required structuralintegrity and support, and reducing weight.

In some embodiments, the program can provide controls which allow theuser to further adjust the shape of the plate, while also allowing theuser to select other plate parameters, such as wedge types andpositions, spacing distance, spacer types and positions, etc. Once theshape and configuration of the plate have been finalized, the computerprogram can generate a 3D model of the plate. As can be appreciated, thecontours of the plate, wedge and/or spacing elements (if applicable) inthe generated 3D model can be configured to conform to the contours ofthe surfaces of the patient's bone (and internal surfaces of the openwedge formed therein, if applicable) as described in the 3D model of thepatient's bone. For example, the computer program can determine anexpected position of wedge and/or spacing element relative to the boneusing the 3D model, determine the expected surface contours at thatposition, and configure the surface contours of the wedge and/or spacingelement to conform to the bone contours at that position.

A fourth step 807 of the preoperative planning method can comprisedesigning a custom surgical guide for assisting in opening the patient'sbone to the selected opening angle and installing the fixation plate. Asdescribed above, the 3D model of the patient's bone can be used tosimulate different steps of the surgical procedure and determined theexpected shape of the patient's bones at the different steps.Accordingly, the computer program can be configured to use the 3D modelto design a surgical guide with modules configured to conform to theshape of the patient's bone at the different steps, and guide surgicaltools as needed at each step.

For example, the computer program can determine a shape, position,orientation, depth, etc. of a single or biplanar cut to be formed in thepatient's bone to attain the required opening angle. The program canthen design a drilling module and/or a cutting module configured toconform to the patient's unaltered bone, and cooperate with standardsurgical tools such as osteotomes and drill bits to form the cut asplanned. Depending on specified surgical requirements, a plurality ofdrilling and/or cutting modules can be provided, for example to drilland/or cut the patient's bone in different steps, as described above.The guide can further be configured with a guide to position a securitypin to protect the tibial plateau throughout the procedure.

The program can further determine the shape, position, orientation,depth, etc. of fasteners for the fixation plate, and design acorresponding predrilling module configured to cooperate with drill bitsto predrill holes in the patient's bone for receiving the fasteners inthe planned configuration. As described above, in some embodiments, thepredrilling module can be configured to drill holes after the openinghas been formed in the patient's bone. Accordingly, the predrillingmodule can be designed to conform to the patient's bone after theopening has been formed in the bone, and can be configured with apositioning element, such as a wedge, for engaging in the opening. Inother embodiments, the predrilling module can be configured to drillholes for the plate fasteners before the patient's bone is opened.Accordingly, the program can use the 3D model of the patient's bone withthe opening and fastener positions defined therein, and virtually closethe patient's bone using the model to determine the correspondingposition of fasteners on the unopened bone. The program and subsequentlydesign a predrilling module configured to drill holes at positions andorientations in the patient's unopened bone that will correspond withthe selected final positions and orientations of the fasteners after thebone is opened at the selected opening angle.

As can be appreciated, the computer program can design further modulesto assist in the surgical procedure, including anchor modules, openingvalidators, etc. as described above. Each of the modules can beconfigured to conform to the patient's bone based on the 3D model. Ascan be further appreciated, the modules can be based off premadetemplates, and customized to conform to patient-specific geometry and toguide surgical tools based on the preoperative plan. Once the guide andits modules have been designed, the computer program can generate 3Dmodels of the same.

Once the custom fixation plate, surgical guide and modules have beendesigned using the computer program, a fifth step 809 of thepreoperative planning method can comprise manufacturing the plate,surgical guide and modules. The plate, guide and modules can bemanufactured using the 3D models generated in the previous steps. Forexample, the 3D models can be used to direct additive manufacturingtechniques, such as 3D printing, to physically create the plate, guideand modules as designed. In some embodiments, the pieces can be printed,and subsequently refined using machining techniques and tools. In someembodiments, the plate and spacers (if applicable) can be manufacturedusing metal, whereas the guide and modules can be manufactured usingplastic.

After the various components have been manufactured, a final step 811 ofthe preoperative planning method can comprise providing the componentsas part of a surgical kit. As shown in FIGS. 31A and 31B, the surgicalkit can include a combination of patient-specific components 900 b andgeneric surgical tools 900 a for use therewith. For example, thesurgical kit can include patient-specific components 900 b such as thefixation plate 600 and the surgical guide 100, including the drillingmodule, cutting module, anchor module, predrilling module 300, openingvalidator 500, drill depth guided 203, etc., as described above. Thesurgical kit can further include a collection or container 901 of theplurality of fasteners 609 chosen to secure the fixation plate inaddition to fasteners 109 for securing the surgical guide 100 andmodules. In some embodiments, physical models 903, 905 of the patient'sbone can be provided, representing the shape of the patient's bonebefore and/or after the opening is formed therein. Finally, the genericcomponents 900 a in the surgical kit can include surgical tools forcooperating with the patient-specific components, such as cutting pliers907, a spreader module 400, a screwdriver and/or screw bit 909, 911, asecurity pin 111, calibrated drill bits 200, osteotomes 913, an explorertool 915, etc., as described above. As can be appreciated, the genericcomponents and/or the patient-specific components can be appropriatelylabelled to assure the correct tools are used in cooperation with thecorrect patient-specific components. Although a particular set ofcomponents has been described, it is appreciated that the kit caninclude fewer or more components, depending on the requirements of thesurgical procedure.

Surgical Procedure

As can be appreciated, the surgical kit described above can be used toassist in a high-tibial osteotomy procedure to correct the alignment ofa patient's knee in accordance with the preoperative plan.

As shown in FIGS. 1A and 1B, a first step of the surgical procedure cancomprise positioning the surgical guide 100 on the patient's tibia bone3. As can be appreciated, the bone interface side 101 of guide isconfigured to conform to the surface of the patient's bone 3 at apredetermined position. Therefore, an explorer tool can be used to helpposition the surgical guide 100 correctly, for example by verifying thatthere are no gaps between the bone interface side 101 and the surface ofthe patient's bone 3.

Once the guide 100 has been positioned, fasteners 109 can be screwedinto the anterior section 107, and then into the lateral section 105 tosecure the guide 100 to the patient's bone 3. As can be appreciated,drill bits can be used to predrill holes to prepare for receiving thefasteners 109, if necessary.

After the guide 100 has been secured, security pin 111 can be insertedinto the patient's bone 3 through security pin guide 112. The patient'sbone 3 can then be weakened in preparation for forming planar cut 5. Inthis step, calibrated drill bits 200 (as shown in FIGS. 2 and 2A) areinserted through guide cylinders 120 in drilling module 113. Thedrilling module 113 is then removed by severing connecting members 121a, 121 b and 121 c, thereby exposing cutting module 117.

An osteotome is inserted through osteotome guide 127 of cutting module117, and the patient's bone 3 can be cut along the area weekend by drillholes to define planar cut 5 with a hinge axis 9. The cutting module 117can subsequently be removed by severing connecting members 123 a and 123b, and removing fasteners 109 in anterior section 107, leaving onlylateral section 105 attached to the bone, along with anchor module 119.

With reference now to FIGS. 3A and 3B, after the cutting module 117 hasbeen removed, pre-drilling module 300 can be positioned relative to thepatient's bone 3 by engaging with anchor module 119. Drill bits 200 cansubsequently be inserted into drill guides 307 to create the drill holes308 for eventually receiving fasteners for securing the fixation plate.

As shown in FIGS. 4, 4A and 4B, after drill holes 308 have been formed,spreader module 400 can engage with anchor module 119, and connectingmember 126 can be severed, allowing proximal 125 a and distal 125 bsections of anchor module 119 to be spread apart from one another. Thespreader module 400 can be operated towards its open configuration 400 buntil the desired opening angle in indicated through window 415 of thespreader module's 400 angle scale. As shown in FIGS. 5 and 5 a, theopening validator 500 can be inserted into the opening 7 formed in thepatient's bone to confirm that it has been opened to the exact desiredopening angle. If opening validator 500 does not fit snugly, spreadermodule 400 can be adjusted to increase or decrease the angle of opening7, until opening validator 500 fits properly.

As shown in FIG. 6A, once the bone 3 has been opened to the desiredangle, fixation plate 600 can secure the bone 3 to retain the opening atthe desired angle. In the present embodiment, the drill holes 308 havealready been created for receiving plate-securing fasteners 609.Accordingly, plate 600 can be positioned on the patient's bone 3 suchthat drill holes 308 line up with fastener apertures 610 of plate 600.Positioning of the plate 600 can be further confirmed, if necessary,using an explorer tool to confirm that there is no spacing between coneinterface side 603 of plate 600 and the surface of the patient's bone 3.Once the position of plate 600 is confirmed, it can be secured byinserting fasteners 609 into the corresponding fastener apertures 610.After the plate is secured, the surgical procedure is complete, andspreader module 400 can be removed from anchor module 119, anchor module119 can be removed from the patient's bone 3 by removing its fasteners109, and security pin 111 can be removed, leaving only plate 600attached to patient's bone 3.

Although the exemplary procedure described above was in connection witha high-tibial open-wedge osteotomy, it is appreciated that similar stepscan apply in connection with a closed-wedge osteotomy. Moreover,although the surgical procedure was described with a particular set andconfiguration of tools, it is appreciated that a similar procedure canbe applied using a different set and configuration of tools. Forexample, similar steps can apply mutatis mutandis when a plurality ofdrilling modules are provided (ex: when connected to cutting module viaa clip mechanism), when predrilling module is configured to drill holesfor plate-securing apertures after the bone is opened, when plate isprovided with a wedge, etc.

While the above description provides examples of the embodiments, itwill be appreciated that some features and/or functions of the describedembodiments are susceptible to modification without departing from thespirit and principles of operation of the described embodiments.Accordingly, what has been described above has been intended to beillustrative and non-limiting and it will be understood by personsskilled in the art that other variants and modifications may be madewithout departing from the scope of the invention as defined in theclaims appended hereto.

The invention claimed is:
 1. A surgical kit for performing a bonesurgery, the surgical kit comprising: an anchor module configured to besecured to a patient's bone, the anchor module having a bone interfaceside with a bone-contacting surface configured to be superposableagainst the patient's bone and an operative side opposite thebone-contacting surface with a removable module interface extendingoutwardly from the operative side, wherein the bone-contacting surfaceis configured to conform to a surface of the patient's bone in apredetermined bone-contacting configuration; a cutting module having acutting module bone interface side with a cutting module bone-contactingsurface configured to be superposable against the patient's bone and acutting module operative side, the cutting module having a slotextending therethrough along a plane and opening on the cutting modulebone interface side and the cutting module operative side, wherein thebone-contacting surface of the anchor module is configured to contactthe patient's bone on both sides of the plane; and a first connectingmember extending from the cutting module operative side to the removablemodule interface of the anchor module, the cutting module being spacedfrom the anchor module by an open space and connected thereto via thefirst connecting member extending across the open space, the firstconnecting member having a portion thereof extending between the cuttingmodule and the anchor module, the portion of the first connecting memberbeing spaced from the cutting module operative side and the operativeside of the anchor module and is configured to enable disconnection ofthe cutting module from the anchor module; and a second connectingmember extending across the open space from the cutting module operativeside to the operative side of the anchor module and connecting to theanchor module at a position adjacent the removable module interface. 2.The surgical kit according to claim 1, further comprising at least onecalibrated drill bit and at least one drill module removably engageablewith the cutting module in a predetermined configuration, the at leastone drill module being configured to guide the at least one calibrateddrill bit to predetermined positions, depths and/or orientations in thepatient's bone.
 3. The surgical kit according to claim 2, furthercomprising one or more osteotomes, and wherein the cutting modulecomprises an osteotome guide extending outwardly and including sidewallsdefining the slot, wherein the osteotome guide is configured to guidethe one or more osteotomes to predetermined positions, depths and/ororientations in the patient's bone and to define a connecting interfacefor the at least one drill module.
 4. The surgical kit according toclaim 3, wherein the slot has a planar shape.
 5. The surgical kitaccording to claim 3, wherein the at least one drill module isengageable with the cutting module over the osteotome guide.
 6. Thesurgical kit according to claim 2, wherein the at least one calibrateddrill bit comprises an abutment member and the at least one drill modulecomprises a body removably engageable with the cutting module and aplurality of drilling guides extending parallel to one another, each oneof the plurality of drilling guides including a guide tunnel defining aguide barrel, each one of the guide barrels defining a respective one ofthe predetermined depths of the at least one calibrated drill bit,wherein the at least one calibrated drill bit is removably insertable inat least one of the guide barrels with the abutment member abuttingagainst a free end of a corresponding one of the at least one of theguide barrels when the respective predetermined depth of the at leastone calibrated drill bit is reached.
 7. The surgical kit according toclaim 2, wherein the at least one drill module comprises at least twodrill modules, each having a body removably engageable with the cuttingmodule and a plurality of drilling guides, extending parallel to oneanother, the plurality of drilling guides of a first one of the at leasttwo drill modules being oriented in a first orientation and theplurality of drilling guides of a second one of the at least two drillmodules being oriented in a second orientation defining an oblique anglewith the first orientation.
 8. The surgical kit according to claim 1,wherein the slot extends in a single plane.
 9. The surgical kitaccording to claim 1, wherein the anchor module comprises two sections,each one of the two sections comprising a portion of the removablemodule interface, the portions of the removable module interfaceconnected to one another with a severable connector, wherein each one ofthe portions of the removable module interface comprises a femaleconnector, and wherein the two sections of the anchor module are locatedon respective sides of the slot of the cutting module when connectedtogether.
 10. The surgical kit according to claim 9, further comprisingat least one calibrated drill bit and at least one predrilling modulehaving a predrilling bone interface side with a predrillingbone-contacting surface configured to be superposable against thepatient's bone, a predrilling operative side, and at least two drill bitapertures extending therethrough and configured to guide the at leastone calibrated drill bit to predetermined positions, depths and/ororientations in the patient's bone corresponding to planned positions,depths and/or orientations of fixation plate fasteners.
 11. The surgicalkit according to claim 10, wherein the at least one predrilling modulecomprises male connectors and is removably engageable with the anchormodule by engaging the male connectors into the female connectors of theportions of the removable module interface of the anchor module.
 12. Thesurgical kit according to claim 9, further comprising a spreader moduleremovably engageable with the anchor module and comprising two arms,each one of the two arms having a male connector engageable with arespective one of the female connectors of the portions of the removablemodule interface to space apart the two sections of the anchor modulewhen secured to the patient's bone.
 13. The surgical kit according toclaim 9, wherein each one of the two sections of the anchor modulecomprises at least one fastener aperture extending therethrough, andwherein the surgical kit further comprises bone fasteners insertable ineach of the at least one fastener aperture to be configured to affix thetwo sections of the anchor module directly to the patient's bone in thepredetermined bone-contacting configuration.
 14. The surgical kitaccording to claim 13, wherein the at least one fastener aperture ofeach one of the two sections of the anchor module comprises at least twofastener apertures.
 15. The surgical kit according to claim 1, furthercomprising at least one calibrated drill bit and at least onepredrilling module having a predrilling bone interface side with apredrilling bone-contacting surface configured to be superposableagainst the patient's bone, a predrilling operative side, and at leasttwo drill bit apertures extending therethrough and configured to guidethe at least one calibrated drill bit to predetermined positions, depthsand/or orientations in the patient's bone corresponding to plannedpositions, depths and/or orientations of fixation plate fasteners. 16.The surgical kit according to claim 1, wherein the first connectingmember extending from the cutting module operative side to the removablemodule interface of the anchor module is a first severable connectingmember.
 17. The surgical kit according to claim 16, comprising aplurality of other severable connecting members including the secondconnecting member, each of the plurality of other severable connectingmembers comprising a stem connected to the cutting module at a first endthereof, and to the anchor module at a second end thereof, and whereineach stem comprises a rounded intermediate section extending between thecutting and anchor modules and being configured to be severed.
 18. Thesurgical kit according to claim 1, wherein the cutting module comprisesfastener apertures extending therethrough with at least one of thefastener apertures being located on each side of the slot and whereinthe surgical kit further comprises bone fasteners insertable in thefastener apertures of the cutting module to be configured to affix thecutting module directly to the patient's bone in a predetermined affixedconfiguration.
 19. The surgical kit according to claim 1, wherein thepatient's bone is a tibia.